IDEALRecalls & reported problems across all models

We found 7 models of IDEAL by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 247 adverse event reports in the FDA's MAUDE database, received between Feb 12, 2018 and Sep 21, 2026 — classified as 2 injuries, 245 malfunctions.

The most frequently reported specific device problem is “Break” (122 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported IDEAL problems

IDEAL models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• IDEAL 251005

  INSTRUMENT, LIGATURE PASSING AND KNOT TYING
  99 reports
• IDEAL 251003

  INSTRUMENT, LIGATURE PASSING AND KNOT TYING
  87 reports
• IDEAL 251004

  INSTRUMENT, LIGATURE PASSING AND KNOT TYING
  42 reports
• IDEAL 251002

  INSTRUMENT, LIGATURE PASSING AND KNOT TYING
  6 reports
• IDEAL 251007

  INSTRUMENT, LIGATURE PASSING AND KNOT TYING
  6 reports
• IDEAL 251006

  INSTRUMENT, LIGATURE PASSING AND KNOT TYING
  4 reports
• IDEAL 251001

  INSTRUMENT, LIGATURE PASSING AND KNOT TYING
  3 reports

Recent IDEAL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  It was reported that during an unknown procedure, it was discovered that the suture shuttle ring on the IDEAL SUTURE SHUTTLE 90 DEGREES device broke off. It was not reported if there were any delays to the surgical procedure. It was reported that a spare device was used to complete the surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845270 ↗
• MalfunctionSep 15, 2026Break; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776895 ↗
• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757261 ↗
• MalfunctionAug 5, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50138754 ↗
• MalfunctionAug 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122226 ↗
• MalfunctionJul 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25766482 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE THE TIP OF THE WIRE LOOP PART BROKE. THERE WAS NOTHING REMAINING IN THE BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488177 ↗
• MalfunctionJun 9, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE WHEN THE SURGEON TRIED TO THREAD THE SUTURE THROUGH THE SUBSCAPULARIS TENDON, THE WIRE TIP BECAME DIFFICULT TO ACCESS. FURTHERMORE, WHEN THE SURGEON TRIED TO PASS THE SUTURE THROUGH THE LOOP, THE WIRE TWISTED, PREVENTING THE SECOND STITCH FROM BEING COMPLETED.. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FRAGMENTS LEFT WITHIN THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448487 ↗
• MalfunctionJun 9, 2026Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE IDEAL SUTURE SHUTTLE RING BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25441457 ↗
• MalfunctionJun 1, 2026Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE CHIA WIRE ON THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE COULD NOT SLIDE. 4.75 HEALIX ADVANCE KNTLSS BR DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE ANCHOR BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354393 ↗
• MalfunctionMay 28, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, WHILE USING THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE, IT WAS OBSERVED THAT THE SUTURE SHUTTLE RING WAS LOOSE. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25323148 ↗
• MalfunctionMay 28, 2026Unintended Movement

  IT WAS REPORTED THAT DURING AN AUDITORY BRAINSTEM RESPONSE (ABR) PROCEDURE A PIECE OF PLASTIC ATTACHED TO THE GROOVE NEXT TO THE WIRE STORAGE HANDLE OF THE IDEAL SHUTTLE 45 DEGREES RIGHT DEVICE CAME LOOSE. THE LOOSE PLASTIC CAUSED THE WIRE TO CATCH IN THE GROOVE AND HINDERED THE SHUTTLE'S MOVEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER SHUTTLE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317981 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, WHILE USING A IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE IT WAS OBSERVED THAT THE TIP WAS BROKEN OFF. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO CONTINUE THE PROCEDURE. IT WAS REPORTED THAT IN THE SAME PROCEDURE, WHEN USING A VAPR PREMIERE50 ELECTRODE DEVICE AFTER CONNECTING TO THE GENERATOR, IT WAS OBSERVED THAT DEVICE DID NOT FUNCTION AT ALL, AND THE SCREEN DID NOT SHOW ANY ALERT CODE. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305003 ↗
• MalfunctionMay 26, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, THE IDEAL DEVICE WIRE COULD NOT BE PUSHED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280828 ↗
• MalfunctionMay 5, 2026Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE IDEAL SUTURE WAS INSERTED THROUGH THE ROTATOR CUFF AND REMOVED WITH A RETRIEVER, BUT THE WIRE TIP FRAYED. A NEW ONE WAS INSERTED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25080294 ↗

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