Boston Scientific Recalls Pinnacle Posterior PFR Kits Due to Suture Breakage Risk
Boston Scientific is recalling 24 units of Pinnacle Posterior PFR Kits because the Capio sutures may break or detach.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4).
Plain-English summary
Boston Scientific Corporation is recalling 24 units of the PFR Kit- Pinnacle, Posterior (Model #M0068317100). The recall is due to a potential for the Capio sutures included in the kit to break and/or detach. The product is indicated for tissue reinforcement in women with pelvic organ prolapse.
The affected units are identified by Batch number ML00002919 and GTIN 08714729784449. These devices were distributed worldwide, including in the United States, Canada, Mexico, Brazil, and numerous countries in Europe, Asia, and the Middle East.
This is a Class II recall. Consumers and healthcare providers should stop using the affected kits and contact Boston Scientific Corporation for further instructions.
The recalled product
- Product
- PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 08714729784449. Batch number: ML00002919
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 11 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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