PERMATAPERecalls & reported problems across all models

We found 9 models of PERMATAPE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2019 and Mar 17, 2026 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 PERMATAPE problems

PERMATAPE models

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

• PERMATAPE 223170

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  6 reports
• PERMATAPE 223169

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  5 reports
• PERMATAPE 223165

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  3 reports
• PERMATAPE 280782

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  3 reports
• PERMATAPE 280779

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  2 reports
• PERMATAPE 280778

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report
• PERMATAPE 280780

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report
• PERMATAPE 280781

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report
• PERMATAPE 280783

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report

Recent PERMATAPE adverse event reports

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

• MalfunctionMar 17, 2026Crack

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION FOR ANTERIOR CRUCIATE LIGAMENT INJURY, WHEN USING THE PERMATAPE 1.3 W/B MO7 NDL 1PK TO SUTURE THE GRAFT FOR RECONSTRUCTION, THE SURGEON NOTICED A TEAR AND FRAY NEAR THE CENTER OF THE TAPE. THE SURGEON STOPPED USING IT AND USED A DIFFERENT PRODUCT OF THE SAME TYPE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619966 ↗
• MalfunctionNov 17, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, WHILE CREATED THE GRAFT, IT WAS OBSERVED THAT THE PERMATAPE 1.3 BLU MO7 NDL DEVICE HAD A HOLE. ACCORDING TO THE REPORTER, IT WAS A MINOR HOLE BUT THE DEVICE WAS REMOVED AND A NEW PRODUCT OF THE SAME PART NUMBER WAS OPENED AND USED. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575591 ↗
• MalfunctionJul 28, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN THE NURSE WAS ABOUT TO OPEN THE PACKAGING OF THE PERMATAPE 1.3 BLU OS6 NDL 1PK DEVICE AT THE SURGEON¿S INSTRUCTION, IT WAS OBSERVED THAT THE PACKAGING WAS ALMOST COMPLETELY OPENED. IT WAS REPORTED THAT THE DEVICE WAS NOT USE, AND ANOTHER DEVICE WAS OPENED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22634203 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A QUADRICEPS TENDON REPAIR SURGICAL PROCEDURE FOR A QUADRICEPS TENDON TEAR, IT WAS OBSERVED THAT WHILE USING THE PERMATAPE 1.3 W/B OS6 NDL1PK DEVICE, AT THE TIME OF MAKING A KNOT, THE PERMATAPE DEVICE SNAPPED EVEN THOUGH THE SURGEON DID NOT APPLY STRONG TENSION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO FOREIGN OBJECTS LEFT IN THE BODY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542194 ↗
• MalfunctionJun 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A UNITE SURGICAL PROCEDURE WHILE USING THE PERMATAPE 1.3 BLU OS6 NDL 1PK DEVICE, THE SUTURE SNAPPED DURING TYING. SINCE THE SUTURE SNAPPED AFTER A HEAD WAS INSTALLED, IT WAS DIFFICULT TO PASS THE SUTURE BETWEEN THE COLLAR AND HEAD, BUT THE SURGEON MANAGED TO COMPLETE IT WITHOUT ANY PROBLEMS. THERE SURGERY TIME WAS EXTENDED BUT NO MORE THAN THIRTY MINUTES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289733 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR (ARCR) PROCEDURE, IT WAS OBSERVED THAT THE PERMATAPE 1.3 W/B OS6 NDL1PK SUTURE DEVICE BROKE MIDWAY THROUGH AND COULD NO LONGER BE USED. IT WAS REPORTED THAT THERE WAS NO RESIDUE OF THE DEVICE LEFT IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941941 ↗
• MalfunctionFeb 24, 2025Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN THE SURGEON ATTEMPTED TO INSERT THE PERMATAPE 1.3 W/B DEVICE INTO THE INSIDE ANCHOR, HE FELT A STUCK SENSATION. ACCORDING TO THE REPORTER, WHEN THE SURGEON PULLED THE DEVICE BACK ONCE TO CHECK, IT WAS FOUND THAT THERE WAS A KNOT IN THE TAPE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444428 ↗
• MalfunctionDec 11, 2024Break; Break

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT AFTER THE PERMATAPE 1.3 W/B OS6 NDL DEVICE PASSED THROUGH THE TISSUE, THE TAPE BROKE DURING SUTURING. IT WAS REPORTED THAT THERE WAS NO SITUATION THAT WOULD HAVE DAMAGED THE TAPE. ANOTHER LIKE DEVICE WAS USED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY, NO PIECES LEFT IN THE BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909800 ↗
• MalfunctionJul 2, 2024Break; Material Deformation; Break; Material Deformation

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED THROUGH CLINICAL RESEARCH THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE PERMATAPE 2.5 BLUE DEVICE WAS DEFORMED, WARPED AND DISTORTED THAT LED TO DEVICE BREAKAGE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657507 ↗
• InjuryAug 31, 2023Break; Break

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE OF THE RIGHT KNEE ON (B)(6) 2023 TREATING AN ACL TEAR. ACCORDING TO THE REPOT, A PERMATAPE SUTURE, BLUE BRAIDED FLAT SUTURE, 2.5MM (6 PACK) DEVICE WAS USED THAT BROKE POSTOPERATIVELY. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A RE-OPERATION/REVISION PROCEDURE FOR LOOSE BODY REMOVAL. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17662386 ↗
• MalfunctionAug 7, 2023Migration; Migration

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP BIOCOMPOSITE ANCHOR DEVICE CAME OUT WHEN THE SURGEON PULLED OUT THE SHAFT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17471440 ↗
• MalfunctionDec 16, 2022Crack; Appropriate Device Problem Term/Code Not Available; Crack; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN SURGERY FOR FRACTURE OF PROXIMAL END OF HUMERUS AND GREATER TUBEROSITY FRACTURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE PERMATAPE SUTURE, WHITE/BLUE BRAIDED FLAT SUTURE, 2.5MM GOT DAMAGED AND FRAYED WHILE THE SURGEON WAS TRYING ATTACHING SUTURE NEEDLES TO THE PERMATAPES REPEATEDLY. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998630 ↗
• MalfunctionDec 16, 2022Crack; Appropriate Device Problem Term/Code Not Available; Crack; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN SURGERY FOR FRACTURE OF PROXIMAL END OF HUMERUS AND GREATER TUBEROSITY FRACTURE ON 11/24/2022, IT WAS OBSERVED THAT THE PERMATAPE SUTURE, BLUE BRAIDED FLAT SUTURE, 2.5MM GOT DAMAGED AND FRAYED WHILE THE SURGEON WAS TRYING ATTACHING SUTURE NEEDLES TO THE PERMATAPES REPEATEDLY. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998591 ↗
• MalfunctionOct 26, 2022Difficult to Advance; Missing Information; Difficult to Advance; Missing Information

  THIS IS REPORT 1 OF 2 FOR PC-(B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A SUBSCAPULARIS TENDON SUTURING PROCEDURE ON THE RIGHT SHOULDER ON (B)(6) 2022 , THE SURGEON FELT SOME STRESS WHEN APPLYING THE PERMATAPE BECAUSE THERE WAS NO NEEDLE. IT TOOK TIME TO PASS THE TAPE THROUGH THE NEEDLE. IT WAS FURTHER REPORTED THAT THE PRODUCT STICKER WAS NOT ON THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY LESS THAN 30-MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15675796 ↗
• MalfunctionOct 26, 2022Difficult to Advance; Missing Information; Difficult to Advance; Missing Information

  THIS IS REPORT 2 OF 2 FOR PC-(B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A SUBSCAPULARIS TENDON SUTURING PROCEDURE ON THE RIGHT SHOULDER ON (B)(6)2022 , THE SURGEON FELT SOME STRESS WHEN APPLYING THE PERMATAPE BECAUSE THERE WAS NO NEEDLE. IT TOOK TIME TO PASS THE TAPE THROUGH THE NEEDLE. IT WAS FURTHER REPORTED THAT THE PRODUCT STICKER WAS NOT ON THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY LESS THAN 30-MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15675791 ↗

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