GEM Microvascular Anastomotic COUPLER GEM2753Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00844735002669), received between Jan 2, 2020 and Jul 27, 2026 — classified as 4 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 reports).

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

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Detachment of Device or Device Component

  It was reported that the ring of a GEM COUPLER,2.5MM had opened. This occurred after a bilateral deep inferior epigastric perforator (DIEP) breast reconstruction procedure. Postoperative monitoring identified right breast swelling and lack of flap flow. The patient was returned to the operating room for re-examination and confirmation of flap failure. During the re-examination, the right sided coupler was observed to be open. The physician reported that the DIEP vein had separated from the internal mammary vein (IMV) at the coupler site; however, the cause of the separation could not be determined. Attempts to recover the flap were unsuccessful. The reporting surgeon stated that the observed irreparable damage to the internal mammary vein suggested an avulsion mechanism rather than an intrinsic defect in the coupler itself. No additional information is available.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50024851 ↗
• MalfunctionJul 22, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25904478 ↗
• MalfunctionJun 19, 2026Failure to Align

  DURING EVALUATION OF A PHOTO SAMPLE, IT WAS OBSERVED THAT A 2.5MM COUPLER HAD MISALIGNED RINGS. THE RINGS APPEARED TO BE SUCCESSFULLY APPROXIMATED AND JOINED, ALTHOUGH THEY APPEARED TO BE SLIGHTLY MISALIGNED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565388 ↗
• MalfunctionFeb 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RING OF A 2.5MM COUPLER DISASSEMBLED DURING USE. THE EVENT WAS FURTHER DESCRIBED AS "IMPLANT HAS SLIPPED OUT OF THE WINGS". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431570 ↗
• MalfunctionFeb 23, 2026Disconnection

  IT WAS REPORTED THAT THERE WAS A DISLODGMENT OF THE RING OF A MICROVASCULAR ANASTOMOTIC COUPLER DEVICE. AFTER ASSEMBLY OF THE COUPLING SYSTEM AND PRIOR TO PERFORMING THE ANASTOMOSIS, ONE OF THE RINGS BECAME DISLODGED FROM THE INSTRUMENT, WHICH PREVENTED SUCCESSFUL ANASTOMOSIS. THE RINGS WERE THEN SAFELY REMOVED, AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A NEW, IDENTICAL DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421446 ↗
• MalfunctionJan 21, 2026Device Dislodged or Dislocated

  IT WAS REPORTED TWO COUPLERS HAD RINGS DISLODGED. DURING A VENOUS ANASTOMOSIS IN THE MAXILLOFACIAL SURGERY UNIT THE USER OBSERVED WHEN CLOSING THE COUPLER THAT THE IMPLANT HAD BECOME DETACHED FROM THE CLAMP USED TO PERFORM THIS PROCEDURE. FOUR DEVICES WERE USED TO COMPLETE THE PROCEDURE, TWO OF WHICH MALFUNCTIONED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137140 ↗
• MalfunctionJan 13, 2026Disconnection

  IT WAS REPORTED THAT THE RINGS OF A 2.5MM COUPLER DISLODGED. THIS WAS OBSERVED DURING ASSEMBLY PRIOR TO PATIENT USE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24062646 ↗
• MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 2.5MM COUPLER HAD DEFECTS. THIS WAS OBSERVED DURING INTRAOPERATIVE STAGE. THE ISSUE WAS DESCRIBED AS "PINS WERE LOOSE IN THE COUPLER". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23398015 ↗
• MalfunctionOct 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RING OF A 2.5MM COUPLER BECAME DISLODGED FROM THE INSTRUMENT. THIS WAS OBSERVED AFTER ASSEMBLY OF THE COUPLING SYSTEM AND PRIOR TO PERFORMING THE ANASTOMOSIS. THE RINGS WERE THEN SAFELY REMOVED, AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A NEW, IDENTICAL DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23249374 ↗
• MalfunctionOct 2, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE RING OF A 3.0MM COUPLER FELL OFF. THIS WAS OBSERVED WHEN THE DEVICE WAS INSERTED FACE-DOWN INTO THE SURGICAL FIELD TO PERFORM AN ANASTOMOSIS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23203128 ↗
• MalfunctionSep 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A 2.5MM COUPLER HAD A LOOSE NEEDLE. THIS WAS OBSERVED WHEN THE DEVICE WAS INSERTED INTO THE PATIENT. THE DEVICE WAS TAKEN OUT OF THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077856 ↗
• MalfunctionSep 10, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE ANASTOMOTIC INSTRUMENT OF A 2.5MM COUPLER WOULD NOT CLOSE. THE ISSUE WAS FURTHER DESCRIBED AS, "THE COUPLER WAS CONNECTED TO THE ANASTOMOTIC INSTRUMENT AND VEIN ATTACHED HOWEVER THE INSTRUMENT WOULD NOT CLOSE WITH THE COUPLER ATTACHED". THIS OCCURRED DURING AN INTRA-OP PROCEDURE. A NEW COUPLER WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014242 ↗
• MalfunctionJul 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 2.5MM COUPLER FAILED TO CLOSE AND LOCK DURING AN ENT CASE. THE ISSUE WAS FURTHER DESCRIBED AS, THE SURGEONS TRIED TO USE A HEMOSTAT TO REINFORCE THE COUPLER LOCKING, AS PER THE INSTRUCTIONS FOR USE (IFU). HOWEVER, ONCE THE COUPLERS WERE DEPLOYED, THEY FAILED TO STAY CLOSED. THIS WAS OBSERVED DURING AN INTRA-OP PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579791 ↗
• MalfunctionJul 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 2.5MM COUPLER FAILED TO CLOSE AND LOCK DURING AN ENT CASE. THE ISSUE WAS FURTHER DESCRIBED AS, THE SURGEONS TRIED TO USE A HEMOSTAT TO REINFORCE THE COUPLER LOCKING, AS PER THE INSTRUCTIONS FOR USE (IFU). HOWEVER, ONCE THE COUPLERS WERE DEPLOYED, THEY FAILED TO STAY CLOSED. THIS WAS OBSERVED DURING AN INTRA-OP PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579751 ↗
• MalfunctionJul 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE (PIN) OF A 2.5MM COUPLER WAS TILTED. THE ISSUE WAS FURTHER DESCRIBED AS, "THE VASCULAR ANASTOMOSIS DID NOT FIT PROPERLY". THIS WAS OBSERVED DURING AN INTRA-OP PROCEDURE. THE ANASTOMOSIS WAS REDONE WITH A NEW DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22533552 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RINGS OF A 2.5MM COUPLER "CAME OFF". THIS WAS OBSERVED AFTER THE DEVICE WAS TIGHTENED AND ANASTOMOSIS HAD BEEN COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22390259 ↗
• MalfunctionJul 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 2.5MM COUPLER HAD FAULTY MATERIAL DURING THE HOOKING STAGE OF THE TWO RINGS. A NEW BATCH WAS USED TO RESOLVE THIS ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375032 ↗
• MalfunctionJun 2, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE RIGHT-SIDE RING OF THREE (3) 2.0MM COUPLERS FELL OFF. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127891 ↗
• MalfunctionApr 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A COUPLER HAD BENT PINS. THE PROCESS STEP WAS NOT SPECIFIED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867532 ↗
• MalfunctionMar 28, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A COUPLER RING DETACHED. THE REPORTER STATED THAT THE RING FELL OFF AND COULD NOT BE USED. THIS OCCURRED DURING THE PREPARATION STAGE BEFORE SURGERY WHILE PREPARING TO ATTACH THE COUPLER TO THE MAIN UNIT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21726701 ↗
• MalfunctionMar 28, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT ONE SIDE OF A COUPLER CAME OFF. THIS OCCURRED WHILE PREPARING TO ATTACH THE COUPLER TO THE MAIN UNIT BEFORE SURGERY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21726177 ↗
• MalfunctionMar 28, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A COUPLER RING WAS DETACHED. THIS OCCURRED WHILE PREPARING TO ATTACH THE COUPLER TO THE MAIN UNIT BEFORE SURGERY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21725643 ↗
• MalfunctionJan 17, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE RING OF A 2.5MM COUPLER FELL OUT OF THE JAW ASSEMBLY; FURTHER DESCRIBED AS "RING FALL ITSELF". THIS WAS OBSERVED BEFORE USING THE DEVICE IN AN OPERATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21185622 ↗
• MalfunctionDec 11, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ONE SIDE CAME LOOSE WHEN THE 2.5 MM COUPLER WAS CLOSED. THIS WAS OBSERVED AFTER THE VEIN WAS HOOKED ON BOTH SIDES OF THE SPIKES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903793 ↗
• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MICROVASCULAR ANASTOMOTIC COUPLER DEVICE RING ¿FALL ITSELF¿. THIS ISSUE OCCURRED PRE-OPERATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879752 ↗