Arthrex® AR-7288Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867369856), received between Sep 28, 2021 and May 12, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 22005291 ↗
• 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 22005290 ↗
• InjuryApr 25, 2025Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  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 INFECTION. DURING A SUBSEQUENT SURGICAL INTERVENTION, THE AR-7288 FIBERTAPE STERNAL CLOSURE AND AR-7289T TIGERTAPE STERNAL CLOSURE WERE EXPLANTED. AS OF (B)(6) 2025, THE PATIENT REMAINS HOSPITALIZED AND CONTINUES RECEIVING IV VANCOMYCIN.

  Patient problems: Erythema; Purulent Discharge; Wound Infection

  MAUDE report 21912893 ↗
• InjuryApr 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  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 21912043 ↗
• InjuryApr 25, 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.

  Patient problems: Wound Infection

  MAUDE report 21909096 ↗
• MalfunctionDec 27, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-7288 FIBERTAPE STERNAL CLOSURE HAD AN ISSUE. THIS WAS DISCOVERED DURING A STERNAL CLOSURE PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: THE NEEDLE ATTACHED TO THE FIBERTAPE BROKE OFF THE SUTURE WHILE INSIDE THE MANUBRIUM. THE NEEDLE WAS LOCATED AND REMOVED, IT REMAINED INTACT. SURGEON OPENED AN AR-7288T TIGERTAPE STERNAL CLOSURE TO COMPLETE THE CASE SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 16052051 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem

  ON 09/07/2021, IT WAS REPORTED THROUGH THE CLINDEX SYSTEM THAT ON (B)(6) 2021 A PATIENT PRESENTED TO THE ED WITH INTERMITTENT, MODERATE, LEFT CHEST PAIN. THE PATIENT UNDERWENT AN INITIAL PROCEDURE ON (B)(6) 2021 WERE FIBERTAPE STERNAL CLOSURE WAS USED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 09/08/2021: THE PATIENT DID NOT HAVE A PROCEDURE ON (B)(6) 2021, THE PI DETERMINED RELATEDNESS ON (B)(6) 2021. THE INITIAL PROCEDURE WAS ON (B)(6) 2021. THE ARTHREX DEVICE USED DURING THE PROCEDURE ARE AS FOLLOWS: AR-7297, LOT: 12532894, QTY. 4. NO REVISION NECESSARY.

  Patient problems: Chest Pain

  MAUDE report 12540091 ↗