Boston Scientific Innova Stent Lawsuit | 2026 Latest Updates

Boston Scientific has recalled its Innova stent twice since 2011. The device is implanted to open narrowed leg arteries. Both recalls followed reports that some stents did not fully release during the procedure. The FDA classified the first recall as Class I in 2011. The second recall was Class II in 2017 and 2018, for 200 mm stents sold in the United States and Canada. This failure can injure a blood vessel or require emergency surgery to remove the stent. Return any affected stent still in inventory to Boston Scientific. The FDA’s newest record lists the 2017/2018 recall as open.

Latest Boston Scientific Innova Stent Recall Updates

February 22, 2018: FDA Posts the Second Innova Stent Recall

Boston Scientific‘s second recall of the Innova Self-Expanding Stent System became public on February 22, 2018. The FDA posted a Class II recall of certain 200 mm stents, per its 2018 record [1]. The recall was numbered Z-0685-2018. It followed reports that the stent could not always fully release from its delivery system.

November 6, 2017: Boston Scientific Initiates the Second Recall

Boston Scientific initiated the 2017/2018 Innova stent recall on November 6, 2017. This is the date the same FDA record lists for when the company began notifying customers. The record shows Boston Scientific sent an Urgent Medical Device letter that day. It told customers to immediately discontinue the affected stents. Customers were told to remove the stents from inventory and return them.

February 4, 2014: FDA Closes the 2011 Innova Stent Recall

The FDA’s 2011 record for the first Innova stent recall shows it was terminated. The termination date was February 4, 2014 [2]. That came nearly three years after Boston Scientific initiated the recall. The 2011 recall was numbered Z-2489-2011. Boston Scientific issued it after receiving complaints about the deployment problem. No further action has been recorded since the recall closed.

June 16, 2011: FDA Posts the First Innova Stent Recall

Diagnostic and Interventional Cardiology reported that the FDA posted the first Innova stent recall on June 16, 2011. Boston Scientific had logged six complaints of stents that did not fully deploy [3]. The recall affected 505 devices. It did not apply to stents already implanted. The failure happens only during the delivery step, before the stent is placed.

May 19, 2011: Boston Scientific Initiates the First Recall

The same FDA record lists May 19, 2011, as the date Boston Scientific initiated the first Innova stent recall. That was about a month before the agency posted the Class I action. The 2011 recall was later closed in 2014. The FDA traced the failure to the stent’s device design, though the FDA’s newest record still lists the second recall as open.

May 13, 2011: Boston Scientific Notifies Customers Outside the U.S.

On May 13, 2011, Boston Scientific sent an urgent recall letter to customers outside the United States. Endovascular Today reported that the letter explained the deployment problem and told customers to stop using the affected stents [4]. The letter also told distributors to stop further distribution right away. They were asked to return unused stents to Boston Scientific. The company gave the same instructions again for the 2017/2018 recall, six years later.

Which Boston Scientific Innova Stents Are Affected?

Two groups of Boston Scientific Innova stents were recalled, each identified by its own catalog or material numbers:

• 2011 recall (Z-2489-2011): the Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-07157 (7 mm x 150 mm x 75 cm), from six specific lot numbers listed in the FDA’s notice.
• 2017/2018 recall (Z-0685-2018): 200 mm Innova stents in eight material-number and diameter combinations, from 5 mm to 8 mm, each with a 75 cm or 130 cm delivery system.

The 2011 stents were distributed nationwide in the United States under the FDA-supervised SuperNOVA investigational trial (IDE #G100291), plus to eight countries outside the U.S. This was a different, earlier version of the device. According to Boston Scientific’s 2015 announcement, the 2017/2018 stents came from the commercial version of the device. The FDA had cleared that version for U.S. sale [5]. Hospitals and physicians holding either product should check their inventory. They can match it against the full lot and batch numbers in the FDA’s recall records before using or reordering the device.

Why Were the Boston Scientific Innova Stents Recalled?

Boston Scientific recalled the Innova stent because some units did not fully release from their delivery system. Some units only partially released. The FDA traced the 2011 recall to the stent’s device design. It traced the 2017/2018 recall to a nonconforming material or component in the delivery system. The two recalls covered different versions of the device. The 2011 version was part of an investigational trial that included sites in the United States as well as the eight countries outside it. The version recalled in 2017 and 2018 was the commercial product. The FDA had approved it for sale in the United States in 2015. Both recalls reported the same underlying problem.

Reported Incidents, Injuries, or Illnesses

Six complaints about the Innova stent reached Boston Scientific before the 2011 recall. The stent had failed to deploy, or only partially deployed, in each case. The FDA’s record for that action describes this. Drug Delivery Business News reported that Boston Scientific pulled the stents after receiving complaints about partial deployment, disclosed through a filing with Germany’s device regulator, the Federal Institute for Drugs and Medical Devices [6]. The FDA’s 2017/2018 record does not list a specific complaint count, unlike the six-complaint count the agency gave for the 2011 recall. The most common problem in both recalls was vessel wall injury. Procedures also took longer than planned. In some cases, patients needed added surgery to remove the stent. These are reports made to regulators and clinicians. They do not by themselves prove the Innova stent caused every vessel injury reported.

What Should Consumers Do?

Anyone who has an affected Boston Scientific Innova stent still in inventory, or who manages a facility that received one, should take the following steps:

1. Stop using any affected Innova stent still in inventory and set it aside so it cannot be implanted.
2. Check the lot, batch, or material numbers against the FDA’s recall records to confirm whether your stock is affected.
3. Return affected stents to Boston Scientific using the company’s Returned Goods Authorization process.
4. Notify any other healthcare professionals at your facility who may have received the affected product.
5. Contact Boston Scientific with questions: 763-494-7971 for the 2011 recall, or 763-494-1133 for the 2017/2018 recall. The company’s complaint line is 800-811-3211.
6. Report any device problem to the FDA’s MedWatch program.

Other Recalls, Warnings, or International Actions

Outside the United States, the 2011 recall covered stents distributed to eight countries: Austria, Finland, France, Germany, Italy, the Netherlands, Spain, and Switzerland. It ran alongside the FDA-supervised SuperNOVA investigational trial in the U.S. The same BfArM filing that made the 2017/2018 recall public also covered stents sent to Canada and named Boston Scientific’s related 150 mm Eluvia stent.

Legal Options

No lawsuit, class action, or multidistrict litigation over the Innova stent recall appears in the JPML‘s pending-MDL list. None appears in searched court records, either [7]. A recall does not automatically establish liability or eligibility. Anyone who believes an Innova stent caused an injury can ask Schmidt & Clark for a review. It can show whether an individual claim may be worth pursuing.

Frequently Asked Questions

What Type of Device Is the Boston Scientific Innova Stent?

The Boston Scientific Innova stent is a laser-cut, self-expanding nitinol stent placed with a triaxial delivery system. Tantalum markers on each end help physicians see it during placement, according to the FDA’s recall record for the device.

Is the Boston Scientific Innova Stent Still Sold?

The Boston Scientific Innova stent is still sold: the company’s current product page lists it as an active product line, offered in diameters and lengths outside the specific lots and material numbers named in the recall notices.

What Is Peripheral Artery Disease?

Peripheral artery disease, or PAD, is a circulatory disorder caused by a build-up of plaque that narrows the arteries, most often in the legs, and it can lead to painful ulcers or infections. The Innova stent is implanted to treat PAD in the superficial femoral and popliteal arteries.

Where Is the Boston Scientific Innova Stent Made?

The Boston Scientific Innova stent is made in Maple Grove, Minnesota, according to the FDA’s recall records for the device, which list a Boston Scientific Corporation address in that city as the manufacturing site named in both the 2011 and 2017/2018 recall filings.

What Is the FDA’s Record Number for the Boston Scientific Innova Stent Recalls?

The FDA’s record numbers for the Boston Scientific Innova stent recalls are 100528 for the 2011 action and 159836 for the 2017/2018 action, and either number can be searched directly in the agency’s public device recall database.

Were There Any Deaths Linked to the Boston Scientific Innova Stent Recall?

No deaths have been linked to the Boston Scientific Innova stent recall. Neither FDA recall record for the Innova stent lists any deaths.

References

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159836
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=100528
3. https://www.dicardiology.com/product/boston-scientific-recalls-innova-self-expanding-stent-system
4. https://evtoday.com/news/boston-scientific-recalls-innova-sfa-stent-system-in-international-markets
5. https://news.bostonscientific.com/2015-08-19-Boston-Scientific-Announces-FDA-Approval-of-Innova-Vascular-Self-Expanding-Stent-System
6. https://www.drugdeliverybusiness.com/boston-scientific-recalls-certain-sizes-eluvia-innova-stents/
7. https://www.jpml.uscourts.gov/pending-mdls-0