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.
What this means for you
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
- 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 →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
Same hazard · device defect
See all →- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
- SevereCannon II Plus Hemodialysis Catheter Recall Due to Sheath Introducer Defect
FDA (Devices) · 2026-05-20