The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1624-2018·Announced 2018-05-16

Boston Scientific Recalls Pinnacle Anterior Apical Pelvic Floor Repair Kits

Boston Scientific is voluntarily recalling 34 Pinnacle Anterior Apical pelvic floor repair kits due to a Class II safety concern. The devices were distributed worldwide.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is voluntarily recalling 34 units of the PFR Kit- Pinnacle, Anterior Apical (Model #M0068317100). These medical devices are indicated for tissue reinforcement in women with pelvic organ prolapse. The recall was initiated on February 12, 2018, and was classified as Class II by the U.S. Food and Drug Administration.

The affected units, identified by Batch number ML00002841 and GTIN 08714729773047, were distributed worldwide to numerous countries including the United States, Canada, and various nations in Europe, Asia, and South America. The recall status is currently terminated, with the termination date recorded as April 10, 2020.

The source text does not specify the exact reason for the recall or report any specific injuries or illnesses associated with the use of these devices. Patients who have had this specific device implanted should contact their healthcare provider for guidance regarding the recall.

The recalled product

Product
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Pelvic Floor Repair
Hazard
Affected units
34

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: 08714729773047 Batch numbers: ML00002841

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.

See all 11 products in this recall →

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