Peripheral RotaLink PlusRecalls & reported problems across all models

We found 6 models of Peripheral RotaLink Plus by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between May 30, 2017 and Feb 6, 2026 — classified as 1 death, 17 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (40 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 Peripheral RotaLink Plus problems

Peripheral RotaLink Plus models

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

• Peripheral RotaLink® Plus M0011402000

  Catheter, peripheral, atherectomy
  1 death21 reports
• Peripheral RotaLink® Plus M0011401500

  Catheter, peripheral, atherectomy
  20 reports
• Peripheral RotaLink® Plus M0011401250

  Catheter, peripheral, atherectomy
  20 reports
• Peripheral RotaLink® Plus M0011401750

  Catheter, peripheral, atherectomy
  9 reports
• Peripheral RotaLink® Plus M0011402500

  Catheter, peripheral, atherectomy
  4 reports
• Peripheral RotaLink® Plus M0011402250

  Catheter, peripheral, atherectomy
  1 report

Recent Peripheral RotaLink Plus adverse event reports

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

• MalfunctionFeb 6, 2026Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR WAS DETACHED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND MODERATELY CALCIFIED POPLITEAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR HIT THE LESION BUT WOULD NOT ADVANCE. UPON REMOVAL OF CATHETER, THE BURR WAS NOT SEEN AND ENDED UP BEING STUCK IN THE HUB OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282629 ↗
• InjuryOct 16, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS DISLODGED AND STUCK IN THE LESION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR TIBIAL ARTERY ATHERECTOMY. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE AND THE DEVICE WERE LODGED IN A CHRONIC OCCLUSION IN THE PERONEAL ARTERY. THE DEVICES COULD NOT BE WITHDRAWN THROUGH THE COMMON FEMORAL ARTERIOTOMY. INTERVENTION INCLUDED EXPOSING THE PERONEAL ARTERY THROUGH THE LOWER LEG TO CUT THE DEVICE FREE AT THE DISTAL END OF THE DEVICE. THE REST OF THE ROTABLATOR WAS REMOVED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310492 ↗
• MalfunctionApr 21, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR GOT STUCK WITH THE WIRE. A 1.50 MM PERIPH ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTALINK CATHETER GOT STUCK IN THE WIRE AND WASN'T ABLE TO ADVANCE. FURTHERMORE, THE WIRE KINKED WHEN THEY TRIED TO ADVANCE THE ROTALINK AND THEY HAVE TO REMOVE EVERYTHING OUT OF THE PATIENT AS THE ROTALINK GOT STUCK IN THE SAME SPOT OF THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873864 ↗
• MalfunctionFeb 25, 2025Entrapment of Device; Device Damaged by Another Device; Intermittent Loss of Power; Entrapment of Device; Device Damaged by Another Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 1.50MM ROTABLATOR ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR STALLED TWICE BEFORE SEIZING UP ON THE WIRE. THE BURR AND WIRE WERE REMOVED AS ONE UNIT, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THE WIRE HAD SHEERED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459875 ↗
• InjuryJul 22, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTABLATOR STOP WORKING. UPON AN ATTEMPT TO REMOVE THE DEVICE, THE TIP GOT DETACHED AND LEFT IN THE LESION. A SNARE WAS USED TO REMOVE THE FRAGMENT AND EXPECTED THE PATIENT FOR A FULL RECOVERY. THE PROCEDURE WAS CANCELLED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795150 ↗
• MalfunctionFeb 19, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR WOULD NOT ADVANCE OR PULL BACK ON WIRE, LODGED IN CALCIFIED AREA AND BROKE IN HALF. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 1.25MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE BURR WAS USED SUCCESSFULLY UNTIL IT DID NOT GO THROUGH A TIGHT CALCIFIED LESION. SUBSEQUENTLY, THE BURR WOULD NOT ADVANCE OR PULL BACK ON WIRE AND SEEMED TO HAVE LODGED IN CALCIFIED AREA; NOT ADVANCING FORWARD OR ON DYNA GLIDE. THE CATHETER AND WIRE WERE THEN PULLED OUT TOGETHER. AFTER REMOVAL, THE BURR WAS REMOVED INTACT BUT BROKE IN HALF (DUE TO CALCIFICATION). THE DETACHED PORTION CAME OUT WITH CATHETER, AND NOTHING WAS LEFT BEHIND. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730411 ↗
• InjuryDec 8, 2023Detachment of Device or Device Component; Intermittent Loss of Power; Detachment of Device or Device Component; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR WAS DETACHED AND REMOVED WITH A SNARE. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL VESSEL. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED TO TREAT THE ENTIRE LENGTH OF THE VESSEL. THE BURR MADE A STALL SOUND WHEN APPROXIMATELY 2-3 INCHES OF THE VESSEL WAS LEFT TO TREAT. THEN, THE ROTAPRO CATHETER WAS REMOVED BUT IT WAS NOTED THAT THE BURR WAS SHEARED OFF AND REMAINED BEHIND ON THE GUIDEWIRE. SNARES WERE USED TO REMOVE THE DEVICE SUCCESSFULLY AFTER ABOUT 3 HOURS OF EXTRA WORK. AFTER THE DETACHED BURR WAS REMOVED, THE VESSEL WAS REWIRED AND BALLOONED TO FINISH THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18295932 ↗
• MalfunctionOct 12, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE ROTALINK BURR WAS STUCK WITH THE ROTAWIRE. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE VERY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND .009 ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTALINK WAS ADVANCED OVER THE ROTAWIRE. HOWEVER, IT WAS NOTED THAT THE ROTAWIRE BECAME STUCK INSIDE THE ROTALINK BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922040 ↗
• MalfunctionJul 31, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER FRACTURE AND FLUID LEAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LESION. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SIDE OF THE CATHETER AT 1/3 OF THE BACK BEHIND BURR WAS FRACTURED AND CAUGHT UPON INSERTION AFTER IT HAD ALREADY BEEN PRIMED. A LEAK WAS ALSO NOTED SO THE FLUID NEVER MADE IT TO THE TIP OF THE CATHETER. THE PORTION OF THE DEVICE WAS OUTSIDE OF THE BODY AT THE TIME OF FRACTURE. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AND 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 17424764 ↗
• InjuryJul 27, 2023Entrapment of Device; Noise, Audible; Intermittent Loss of Power; Entrapment of Device; Noise, Audible; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR STUCK WITH THE WIRE. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND 70% CALCIFIED TIBIAL AREA. A 1.25MM PERIPHERAL ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE MADE AN ABNORMAL SOUND AND IT STOPPED. THE BURR WAS STUCK AND COULD NOT COME OUT AS A WHOLE SYSTEM WITH WIRE. THE DEVICES WERE PULLED OUT USING A NON-BSC SUPPORT CATHETER. IT WAS REPORTED THE WIRE MAY HAVE DETACHED AND THE BURR WAS STUCK. THE DEVICES WERE REMOVED COMPLETELY FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANGIOPLASTY. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405899 ↗
• MalfunctionMar 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BURR DETACHMENT OCCURRED. A 1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THERE WAS NO BURR ATTACHED TO THE CATHETER TIP. IT IS UNKNOWN IF THE BURR WAS ALREADY DETACHED UPON REMOVAL FROM THE PACKAGING OR DETACHED DURING TESTING OF THE DEVICE. THERE WAS NO DAMAGE NOTICED ON THE ORIGINAL PACKAGING. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL ROTALINK PLUS. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542027 ↗
• MalfunctionJan 9, 2023Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, STANDARD SET UP OF THE ROTABLATOR WAS PERFORMED AND SET THE SPEED TO 170K RPM. THE BURR WAS INSERTED TO THE LESION AND SEVERAL ATHERECTOMY RUNS WERE PERFORMED. HOWEVER, WHEN THE LAST RUN WAS PERFORMED, DURING REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE BURR DETACHED FROM THE END OF THE ADVANCER. THE PHYSICIAN STATES THAT THE BURR NEVER STALLED OR STUCK AT ANY POINT. THE ROTABURR AND ROTAWIRE WERE GENTLY PULLED OUT TOGETHER WITHOUT INCIDENT. IN ADDITION, THE PATIENT HAD- AN ABNORMAL LFTS AND/OR BLOOD COUNTS BUT THE DEVICE OR PROCEDURE DID NOT CAUSE OR CONTRIBUTED TO THE PATIENT'S COMPLICATION ACCORDING TO THE PHYSICIAN'S OPINION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16127984 ↗
• InjurySep 30, 2022Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR BROKE OFF AND REMAINED ON THE WIRE, REQUIRING INTERVENTION FOR REMOVAL. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND HEAVY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND ROTAWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS INTRODUCED OVER THE WIRE AND IMBEDDED INTO HEAVY CALCIUM. WHILE SPINNING, THE PHYSICIAN PUSHED THE BURR SLIGHTLY, HOWEVER, THE BURR BROKE OFF AND REMAINED ON THE WIRE. THE DETACHED PORTION OF THE DEVICE WAS REMOVED USING A BERN CATHETER. THE WIRE AND CATHETER WERE SLOWLY REMOVED THROUGH THE GROIN SHEATH ALONG WITH THE BURR. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509244 ↗
• MalfunctionSep 15, 2022Output Problem; Noise, Audible; Output Problem; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE EXCEEDED THE SET OPERATIONAL SPEED. THE TARGET LESION WAS LOCATED IN THE RIGHT ANTERIOR TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS MAKING UNEXPECTED NOISES WHEN THE PEDAL WAS DEPRESSED TO RUN THE DEVICE. ADDITIONALLY, THE DEVICE DID NOT APPEAR TO BE MOVING AS EXPECTED INSIDE THE VESSEL ON THE FLUOROSCOPY. SUBSEQUENTLY, THE SET OPERATIONAL SPEED WAS 176,000 RPM HOWEVER, THE MAXIMUM SPEED REACHED WAS AT 182,000 RPM. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429412 ↗
• MalfunctionAug 26, 2022Entrapment of Device; Device Contamination with Chemical or Other Material; Material Integrity Problem; Noise, Audible; Entrapment of Device; Device Contamination with Chemical or Other Material; Material Integrity Problem; Noise, Audible

  IT WAS REPORTED THAT THE BURR WAS STUCK WITH THE ROTAWIRE AND FOREIGN MATTER WAS NOTED ON THE BURR. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, A PECKING MOTION WAS USED IN ADVANCING THE BURR; HOWEVER, ON THE SECOND PASS, A CONSTANT BOGGING DOWN NOISE ON THE ADVANCER WAS HEARD AND THE BURR WAS RUNNING VERY SLOW. SUBSEQUENTLY, THE BURR GOT STUCK ON THE WIRE AND COULD NOT BE REMOVED. WHEN THE DEVICE WAS PULLED OUT ALTOGETHER FROM THE PATIENT'S BODY, THEY NOTICED A THIN PLASTIC THAT WAS WRAPPED AROUND THE BURR AND SLIGHTLY AROUND THE SHAFT NEAR THE BURR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300477 ↗

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