Sterling™ H74939032402210Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729860310), received between Oct 24, 2018 and May 21, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024Deflation Problem; Material Rupture; Detachment of Device or Device Component; Deflation Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT SLOW DEFLATION, BURST, AND DETACHMENT OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INITIALLY INFLATED AT 6 ATMOSPHERES AND DEFLATED EXTREMELY SLOW. THE BALLOON WAS INFLATED AGAIN, BUT IT RUPTURED AFTER 60 SECONDS. UPON REMOVAL, THE BALLOON RIPPED OFF FROM THE CATHETER AND BECAME STUCK IN THE SHEATH. THE DEVICE WAS REMOVED WITHOUT ANY FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358857 ↗
• MalfunctionMay 10, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON HAD A HOLE. A 4.0X220X150 (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON PREPARATION, IT WAS NOTED THAT THE BALLOON HAD A HOLE. THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286925 ↗
• MalfunctionAug 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, BALLOON RUPTURED BEFORE IT WAS INFLATED TO THE NOMINAL BAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560678 ↗
• MalfunctionAug 16, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.0X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT FAILED AND BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557974 ↗
• InjuryAug 25, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. A 4.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION USING AN ENCORE 26 INFLATION DEVICE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON COULD NOT BE DEFLATED. THE INFLATION DEVICE WAS SWAPPED WITH A NON-BOSTON SCIENTIFIC PRODUCT WHICH DID NOT WORK EITHER. THE BALLOON HAD TO BE EXTRACTED WHILE STILL INFLATED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368503 ↗
• MalfunctionFeb 22, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 4.0X220X150 (4F) STERLING BALLOON CATHETER WAS USED, HOWEVER; THE BALLOON WAS STUCK ON THE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358939 ↗
• MalfunctionAug 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THERE WAS 50% STENOSIS DURING POST ATHERECTOMY. THE BALLOON RUPTURED AT INITIAL INFLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10412522 ↗
• MalfunctionMar 31, 2020Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 4.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DIFFICULTIES WERE ENCOUNTERED UPON INFLATING THE BALLOON. HIGH PRESSURE WAS USED AND ONCE INFLATED, THE BALLOON WOULD NOT DEFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9903498 ↗
• InjurySep 18, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 220 X 150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE BALLOON COULD NOT GET CONTRAST TO DEFLATE AND IT STAYED INFLATED. ANOTHER WIRE WAS ADVANCED AS A BUDDY WIRE TO POP THE BALLOON AND TO GET THE BALLOON OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081152 ↗
• MalfunctionOct 24, 2018Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-OCT-2018. IT WAS REPORTED THAT BALLOON DEFORMATION AND SLOW INFLATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 4.0X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION THERE WAS A TINY PORTION OF THE BALLOON THAT DID NOT INFLATE. IT LOOKS LIKE THERE WAS A RING AROUND THE BALLOON THAT WOULD NOT LET IT INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENTS BODY. THE DEVICE WAS INFLATED ONCE AGAIN TO SEE THE DEFECT. THE PROCEDURE WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE DEVICE EVALUATED BY MANUFACTURER: THE RETURNED ANALYSIS REVEALED THE TIP, BALLOON, MARKERBANDS, AND INNER/OUTER SHAFT WERE MICROSCOPICALLY AND VISUALLY INSPECTED. INSPECTION REVEALED WITNESS MARKS IN THE BALLOON MATERIAL LOCATED 8.2 CM FROM THE TIP, WITH BALLOON DAMAGE (PINCH IN MATERIAL) LOCATED 7 CM AND 21 CM FROM THE TIP, TIP DAMAGE, AND A PINHOLE IN THE BALLOON MATERIAL LOCATED 12 MM DISTAL FROM THE PROXIMAL MARKERBAND. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8000638 ↗