NA H749A70200Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729228684), received between Jun 30, 2020 and Nov 12, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Contamination” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Contamination; Contamination

  It was reported that loss of sterility occurred.A System Accessory pullback sled was used to perform controlled imaging of the target lesion using an intravascular ultrasound catheter. During test period, the entire assembly had become unsterile along with the catheter post-opening. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531347 ↗
• MalfunctionDec 6, 2024Contamination; Contamination

  IT WAS REPORTED THAT A DEVICE STERILITY ISSUE OCCURRED. THE SLED PULLBACK SYSTEM ACCESSORY WAS SELECTED FOR USE AS PART OF AN INTRAVASCULAR ULTRASOUND PROCEDURE. WHEN THE OUTER PACKAGING WAS OPENED, IT WAS NOTED THAT THE SLED WAS ALREADY IN A NON-STERILE STATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860254 ↗
• MalfunctionDec 5, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT AN INNER SEAL ISSUE OCCURRED. A SLED PULLBACK SYSTEM ACCESSORY, PART OF AN ILAB ULTRASOUND IMAGING SYSTEM, WAS SELECTED FOR USE FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PREPARATION, IT WAS NOTED THAT THE INNER PACKAGING WAS DEFORMED AND THE TRANSPARENT CONTAINER ENCASING THE SLED HAD AN INCOMPLETE SEAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857475 ↗
• MalfunctionNov 27, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. THE PULLBACK SLED, A SYSTEM ACCESSORY WHICH WAS PART OF AN ILAB ULTRASOUND IMAGING SYSTEM, WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. WHEN THE OUTER BOX WAS OPENED, IT WAS FOUND THAT THE SEAL OF THE INNER PACKAGE WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800525 ↗
• MalfunctionNov 14, 2024Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A SYSTEM ACCESSORY, WHICH WAS PART OF AN ILAB ULTRASOUND IMAGING SYSTEM, WAS USED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PREPARATION, WHEN THE OUTER PACKAGE WAS OPENED, IT WAS FOUND THAT THE INNER PACKAGE WAS INCOMPLETE AND THE SLED WAS NOT STERILE, MAKING IT UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683560 ↗
• MalfunctionNov 13, 2024Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A SYSTEM ACCESSORY, WHICH WAS PART OF AN ILAB ULTRASOUND IMAGING SYSTEM, WAS USED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PREPARATION, WHEN THE OUTER PACKAGE WAS OPENED, IT WAS FOUND THAT THE INNER PACKAGE WAS INCOMPLETE AND THE SLED WAS NOT STERILE, MAKING IT UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENTS CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675776 ↗
• MalfunctionNov 13, 2024Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A SYSTEM ACCESSORY, WHICH WAS PART OF AN ILAB ULTRASOUND IMAGING SYSTEM, WAS USED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PREPARATION, WHEN THE OUTER PACKAGE WAS OPENED, IT WAS FOUND THAT THE INNER PACKAGE WAS INCOMPLETE AND THE SLED WAS NOT STERILE, MAKING IT UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THE PATIENTS CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675698 ↗
• MalfunctionNov 13, 2024Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A SYSTEM ACCESSORY, WHICH WAS PART OF AN ILAB ULTRASOUND IMAGING SYSTEM, WAS USED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PREPARATION, WHEN THE OUTER PACKAGE WAS OPENED, IT WAS FOUND THAT THE INNER PACKAGE WAS INCOMPLETE AND THE SLED WAS NOT STERILE, MAKING IT UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675645 ↗
• MalfunctionMay 27, 2022Activation, Positioning or Separation Problem

  EARLY 50¿S MALE WITH HISTORY OF CORONARY ARTERY DISEASE. PROCEDURE: HEART CATH, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). DURING PROCEDURE, THE INTRAVASCULAR ULTRASOUND SLED WOULD NOT PULL BACK. NO KNOWN HARM TO PATIENT SLED TO REPORT THAT WOULD NOT PULL BACK. (REFER TO MEDSUN REPORT #(2022-8047) .THE FOLLOWING DAY, ANOTHER SLED THAT WOULD NOT PULL BACK, I CHECKED, AND THEY HAD THE SAME LOT NUMBERS. MANUFACTURER RESPONSE FOR COMPUTER, DIAGNOSTIC, PROGRAMMABLE, NA (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14521576 ↗
• MalfunctionMay 27, 2022Activation, Positioning or Separation Problem

  MID 60¿S FEMALE WITH HISTORY OF MID STERNAL CHEST PAIN X 2 MONTHS. PROCEDURE: HEART CATH, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OF RIGHT CORONARY ARTERY. DURING THE PROCEDURE, THE BOSTON SCIENTIFIC SLED WOULD NOT PULL BACK. NO KNOWN HARM TO PATIENT, ANOTHER DEVICE SUCCESSFULLY USED. MANUFACTURER RESPONSE FOR COMPUTER, DIAGNOSTIC, PROGRAMMABLE, NA (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14521575 ↗
• MalfunctionSep 10, 2020Failure to Transmit Record

  MIDDLE-AGED MALE WITH HISTORY OF CORONARY ARTERY DISEASE (CAD), UNDERGOING AN ANGIOPLASTY AND PERCUTANEOUS CORONARY INTERVENTION (PCI). THE SLED WOULD NOT RECORD. IT WAS UNPLUGGED AND IT WORKED FINE MANUALLY. NO KNOWN HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10513940 ↗
• MalfunctionJun 30, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT BLOOD ON THE DEVICE WAS OBSERVED. THE TORTOUS TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY, LEFT CIRCUMFLEX ARTERY, AND RIGHT CORONARY ARTERY. A SLED SYSTEM ACCESSORY WAS SELECTED FOR USE. HOWEVER, WHEN THE PHYSICIAN UNPACKED THE DEVICE THERE WAS BLOOD ON IT. THE STERILITY OF THE DEVICE WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10214104 ↗