Surgipro SPM-14-WRecalls & reported problems
Covidien LP · Multifilament Polypropylene Mesh · Class 2 · Implant
All models of Surgipro (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521101357), received between Apr 11, 2019 and Apr 11, 2019 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K915526); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Adhesion(s)1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS IMPLANTED DURING A LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING PROCEDURE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS BETWEEN THE ABDOMINAL WALL/OMENTUM AND ADHESIONS ALONG THE MIDLINE AND DOWN BELOW THE UMBILICUS. POST-OPERATIVE TREATMENT INCLUDED TAKING DOWN ADHESIONS AND SURGICAL REVISION.
Patient problems: Adhesion(s); Injury
MAUDE report 8503926 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K915526. One submission often covers many models, so check the product and lot details in each record.
- Z-1009-2011 · Dec 15, 2010 · TerminatedAutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile REF SPM 35 Surgipro Flat Sheet mesh is a non-absorbable, polypropylene surgical mesh exhibiting high burst strength
Other Mesh, surgical, polymeric devices
- PROCEED PVPMJohnson & Johnson International Inc. · Mesh, surgical, polymeric1,233 reports
- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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