Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
FDA adverse event reports and recall history for suture, nonabsorbable, steel, monofilament and multifilament, sterile (product code GAQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 934
- Deaths
- 7
- Injuries
- 208
- Malfunctions
- 712
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2022-09-26Open, ClassifiedEnvironmental control
Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2014-05-07TerminatedEmployee error
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- 2014-05-07TerminatedEmployee error
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- 2014-04-24TerminatedOther
Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.
The products are being recalled because they did not meet minimum diameter requirements.
- TerminatedMaterial/Component Contamination
ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
- TerminatedMaterial/Component Contamination
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Monitor suture, nonabsorbable, steel, monofilament and multifilament, sterile automatically
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