Arthrex® AR-7289TRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867369887), received between Apr 11, 2022 and May 12, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  ON 4/9/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT MECHANICAL AORTIC VALVE REPLACEMENT, A MECHANICAL MITRAL VALVE REPLACEMENT, AND A CORONARY ARTERY BYPASS GRAFT PROCEDURE IN (B)(6) 2025. THE PATIENT'S STERNAL CLOSURE WAS ACHIEVED WITH AN AR-7288 FIBERTAPE STERNAL CLOSURE AND AR-7288T FIBERTAPE STERNAL CLOSURE SYSTEM. THE PATIENT THEN PRESENTED WITH A STERNAL WOUND INFECTION. THE PATIENT UNDERWENT SURGICAL IRRIGATION AND DEBRIDEMENT. THE SURGICAL CULTURES REVEALED CORYNEBACTERIUM AMYCOLATUM. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 4/16/2025: THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2025, DURING WHICH AN AR-7288 FIBERTAPE STERNAL CLOSURE, AN AR-7288T FIBERTAPE STERNAL CLOSURE, AND AN AR-7289T TIGERTAPE STERNAL CLOSURE WERE IMPLANTED. AROUND (B)(6) 2025, THE PATIENT DEVELOPED PURULENT DRAINAGE AND ERYTHEMA AT THE CHEST INCISION SITE. THE INFECTION WAS MANAGED WITH IV ANTIBIOTICS, MULTIPLE IRRIGATION AND DEBRIDEMENT PROCEDURES, WOUND VACUUM-ASSISTED CLOSURES, AND A PECTORAL FLAP FOR CHEST CLOSURE. THE PATIENT UNDERWENT PROCEDURES ON (B)(6) 2025 TO ADDRESS THE ONGOING INFECTIO

  Patient problems: Erythema; Purulent Discharge; Wound Infection

  MAUDE report 22005387 ↗
• InjuryMay 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 4/9/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE IN (B)(6) OF 2025. THE PATIENT'S STERNAL CLOSURE WAS ACHIEVED WITH AN AR-7288 FIBERTAPE STERNAL CLOSURE SYSTEM. THE PATIENT THEN PRESENTED WITH A STERNAL WOUND INFECTION, REQUIRING ADDITIONAL SURGERY. SURGICAL CULTURES REVEALED CORYNEBACTERIUM AMYCOLATUM. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 4/16/2025: THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2025, DURING WHICH FOUR AR-7289T AND THREE AR-7288 IMPLANTS WERE PLACED. AROUND (B)(6) 2025, THE PATIENT BEGAN EXPERIENCING STERNAL WOUND REDNESS, PURULENT DRAINAGE, AND INVASIVE FUNGAL DISEASE. TO ADDRESS THESE COMPLICATIONS, THE PATIENT UNDERWENT MULTIPLE IRRIGATION AND DEBRIDEMENT PROCEDURES ON (B)(6) 2025, FOLLOWED BY BILATERAL PECTORALIS ADVANCEMENT FLAPS FOR CHEST CLOSURE. DURING AN ADDITIONAL SURGICAL PROCEDURE, THE IMPLANTS WERE EXPLANTED; HOWEVER, THE SPECIFIC IMPLANTS REMOVED, AND THE EXACT DATE OF THE SURGERY REMAIN UNCLEAR. THE PATIENT WAS READMITTED ON (B)(6) 2025 FOR A CURRENT STERNAL WOUND INFECTION.

  Patient problems: Wound Infection

  MAUDE report 22005292 ↗
• InjuryMay 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 4/9/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE IN (B)(6) 2025. THE PATIENT'S STERNAL CLOSURE WAS ACHIEVED WITH AN AR-7288 FIBERTAPE STERNAL CLOSURE SYSTEM. THE PATIENT THEN PRESENTED WITH A STERNAL WOUND INFECTION, REQUIRING ADDITIONAL SURGERY. SURGICAL CULTURES REVEALED CORYNEBACTERIUM AMYCOLATUM. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 4/16/2025: THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2025, DURING WHICH FOUR AR-7289T AND THREE AR-7288 IMPLANTS WERE PLACED. AROUND (B)(6) 2025, THE PATIENT BEGAN EXPERIENCING STERNAL WOUND REDNESS, PURULENT DRAINAGE, AND INVASIVE FUNGAL DISEASE. TO ADDRESS THESE COMPLICATIONS, THE PATIENT UNDERWENT MULTIPLE IRRIGATION AND DEBRIDEMENT PROCEDURES ON (B)(6) 2025, FOLLOWED BY BILATERAL PECTORALIS ADVANCEMENT FLAPS FOR CHEST CLOSURE. DURING AN ADDITIONAL SURGICAL PROCEDURE, THE IMPLANTS WERE EXPLANTED; HOWEVER, THE SPECIFIC IMPLANTS REMOVED, AND THE EXACT DATE OF THE SURGERY REMAIN UNCLEAR. THE PATIENT WAS READMITTED ON (B)(6) 2025 FOR A CURRENT STERNAL WOUND INFECTION.

  Patient problems: Wound Infection

  MAUDE report 22005281 ↗
• InjuryMay 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 4/9/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE IN (B)(6) 2025. THE PATIENT'S STERNAL CLOSURE WAS ACHIEVED WITH AN AR-7288 FIBERTAPE STERNAL CLOSURE SYSTEM. THE PATIENT THEN PRESENTED WITH A STERNAL WOUND INFECTION, REQUIRING ADDITIONAL SURGERY. SURGICAL CULTURES REVEALED CORYNEBACTERIUM AMYCOLATUM. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 4/16/2025: THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2025, DURING WHICH FOUR AR-7289T AND THREE AR-7288 IMPLANTS WERE PLACED. AROUND (B)(6) 2025, THE PATIENT BEGAN EXPERIENCING STERNAL WOUND REDNESS, PURULENT DRAINAGE, AND INVASIVE FUNGAL DISEASE. TO ADDRESS THESE COMPLICATIONS, THE PATIENT UNDERWENT MULTIPLE IRRIGATION AND DEBRIDEMENT PROCEDURES ON (B)(6) 2025, FOLLOWED BY BILATERAL PECTORALIS ADVANCEMENT FLAPS FOR CHEST CLOSURE. DURING AN ADDITIONAL SURGICAL PROCEDURE, THE IMPLANTS WERE EXPLANTED; HOWEVER, THE SPECIFIC IMPLANTS REMOVED, AND THE EXACT DATE OF THE SURGERY REMAIN UNCLEAR. THE PATIENT WAS READMITTED ON (B)(6) 2025 FOR A CURRENT STERNAL WOUND INFECTION.

  Patient problems: Wound Infection

  MAUDE report 22005280 ↗
• InjuryMay 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 4/9/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE IN (B)(6) 2025. THE PATIENT'S STERNAL CLOSURE WAS ACHIEVED WITH AN AR-7288 FIBERTAPE STERNAL CLOSURE SYSTEM. THE PATIENT THEN PRESENTED WITH A STERNAL WOUND INFECTION, REQUIRING ADDITIONAL SURGERY. SURGICAL CULTURES REVEALED CORYNEBACTERIUM AMYCOLATUM. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 4/16/2025: THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2025, DURING WHICH FOUR AR-7289T AND THREE AR-7288 IMPLANTS WERE PLACED. AROUND(B)(6) 2025, THE PATIENT BEGAN EXPERIENCING STERNAL WOUND REDNESS, PURULENT DRAINAGE, AND INVASIVE FUNGAL DISEASE. TO ADDRESS THESE COMPLICATIONS, THE PATIENT UNDERWENT MULTIPLE IRRIGATION AND DEBRIDEMENT PROCEDURES ON (B)(6) 2025, FOLLOWED BY BILATERAL PECTORALIS ADVANCEMENT FLAPS FOR CHEST CLOSURE. DURING AN ADDITIONAL SURGICAL PROCEDURE, THE IMPLANTS WERE EXPLANTED; HOWEVER, THE SPECIFIC IMPLANTS REMOVED, AND THE EXACT DATE OF THE SURGERY REMAIN UNCLEAR. THE PATIENT WAS READMITTED ON (B)(6) 2025 FOR A CURRENT STERNAL WOUND INFECTION.

  Patient problems: Wound Infection

  MAUDE report 22005279 ↗
• InjuryMay 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 4/9/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE IN (B)(6) 2025, DURING WHICH A FIBERTAPE STERNAL CLOSURE WAS USED. THE PATIENT THEN PRESENTED WITH A CORYNEBACTERIUM AMYCOLATUM STERNAL WOUND INFECTION, REQUIRING ADDITIONAL SURGERY. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 4/16/2025: THE PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2025, DURING WHICH AN AR-7288 FIBERTAPE STERNAL CLOSURE, AN AR-7289T TIGERTAPE STERNAL CLOSURE, AND AN AR-7288T TIGERTAPE STERNAL CLOSURE WERE IMPLANTED. POSTOPERATIVELY, ON (B)(6) 2025, THE PATIENT DEVELOPED STERNAL WOUND DRAINAGE, GAS ACCUMULATION, AND FLUID COLLECTION EXTENDING TO THE MEDIASTINUM. TO ADDRESS THESE COMPLICATIONS, THE PATIENT REQUIRED MULTIPLE IRRIGATION AND DEBRIDEMENT PROCEDURES, ALONG WITH WOUND VACUUM-ASSISTED CLOSURES, PERFORMED ON (B)(6) 2025. FOLLOWING THESE INTERVENTIONS, THE PATIENT UNDERWENT A BILATERAL PECTORALIS FLAP PROCEDURE FOR CHEST CLOSURE. DURING AN ADDITIONAL SURGICAL PROCEDURE, THE IMPLANTS WERE EXPLANTED; HOWEVER, THE SPECIFIC IMPLANTS REMOVED, AND THE EXACT DATE OF THE S

  Patient problems: Bacterial Infection; Pain; Wound Infection

  MAUDE report 22004284 ↗
• InjuryMay 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 4/9/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT, TISSUE AND CORONARY ARTERY BYPASS GRAFT, AND REPAIR TRICUSPID VALVE PROCEDURE IN (B)(6) 2025. THE PATIENT'S STERNAL CLOSURE WAS ACHIEVED WITH AN AR-7288 FIBERTAPE STERNAL CLOSURE. THE PATIENT THEN PRESENTED WITH A STERNAL WOUND INFECTION, REQUIRING ADDITIONAL SURGERY. SURGICAL CULTURES REVEALED CORYNEBACTERIUM AMYCOLATUM. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 4/16/2025: THE FACILITY REPRESENTATIVE CONFIRMED THAT, IN ADDITION TO THE AR-7288 FIBERTAPE STERNAL CLOSURE, AN AR-7289T TIGERTAPE STERNAL CLOSURE, AND AN AR-7288T TIGERTAPE STERNAL CLOSURE WERE IMPLANTED DURING THE INITIAL SURGERY ON (B)(6) 2025. THE PATIENT BEGAN EXPERIENCING SYMPTOMS ON (B)(6) 2025, INCLUDING CHEST PAIN, CHEST WALL ABSCESS, AND MEDIASTINITIS. THE INFECTION, IDENTIFIED AS CORYNEBACTERIUM AMYCOLATUM, REQUIRED MULTIPLE TREATMENTS, INCLUDING DEBRIDEMENT AND IRRIGATION OF THE CHEST, A PECTORALIS MUSCLE FLAP FOR CLOSURE, AND WOUND VACUUM-ASSISTED CLOSURE. THESE INTERVENTIONS WERE PERFORMED ON (B)(6) 2025. DURING AN ADDITIONA

  Patient problems: Bacterial Infection; Pain; Wound Infection

  MAUDE report 21993365 ↗
• InjurySep 13, 2023Material Frayed; Material Frayed

  ON 08/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT QTY. 4 OF AN AR-7289T TIGERTAPE STERNAL CLOSURE WITH ATTACHED BLUNT TAPERED NEEDLE HAD AN ISSUE. THE TAPES WERE FRAYED AT THE TIP OF THE TENSIONER TO THE POINT THAT THERE WAS ONLY ONE STRAND OF SUTURE LEFT. THEY WERE NOT ABLE TO TIE A KNOW TO HOLD TENSION. THE TENSIONER DID NOT GO PAST THE 80 LINE. THE TAPES WERE REMOVED, THE PATIENT'S HEALTH WAS NOT COMPROMISED. THE DEVICES WERE DISCARDED AFTER THE CASE, AND NO PICTURES WERE TAKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 8/21/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION VIA EMAIL: THIS OCCURRED DURING A STERNAL CLOSURE CERCLAGE PROCEDURE ON (B)(6) 2023. TWO AR-7800 FIBERTAPE CERCLAGE TENSIONER, REUSABLE DID NOT GOT PAST THE 80 LINE, ONE DEVICE WITH LOT NUMBER 051912 AND ONE DEVICE WITH LOT NUMBER 051650. NO PIECES OF THE TENSIONERS BROKE, BUT THE FIBERTAPE TAIL THAT SITS IN THE TOP SLOT OF THE TENSIONER. ALL FRAGMENTS OF THE FIBERTAPES WERE REMOVED. THE CASE WAS COMPLETED BY PULLING THE FIBERTAPES OUT AND USING WIRES AND PLATES TO CLOSE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT REPORTED AND NO CASE DELAY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17735566 ↗
• MalfunctionApr 11, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-7289T TIGERTAPE STERNAL CLOSURE HAD ONE NEEDLE BREAK AS IT WAS PASSED THROUGH THE STERNUM AND ANOTHER NEEDLE BROKE FREE OF THE TIGERTAPE SUTURE AS IT WAS BEING PASSED. ALL BROKEN FRAGMENTS WERE RETRIEVED AND CASE WAS COMPLETED USING (2) AR-7289T TIGERTAPE STERNAL CLOSURE FROM THE SAME LOT NUMBER. THIS WAS DISCOVERED DURING A STERNAL CLOSURE PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075202 ↗