Instrument, Ligature Passing And Knot Tying
FDA adverse event reports and recall history for instrument, ligature passing and knot tying (product code HCF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 628
- Deaths
- 6
- Injuries
- 71
- Malfunctions
- 544
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
- 2024-01-31Open, ClassifiedNonconforming Material/Component
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
- 2024-01-31Open, ClassifiedNonconforming Material/Component
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
- 2023-05-09TerminatedUnder Investigation by firm
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
The plastic housing on the device may fracture
- TerminatedOther
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
The devices wings may become partially detached from the EFx Shield during use.
- TerminatedUnknown/Undetermined by firm
Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
Incorrect expiration date was printed on the product label.
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