Peripheral RotaLink® Plus M0011401500Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729838906), received between May 31, 2017 and Apr 21, 2025 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJul 20, 2022Fracture; Noise, Audible; Fracture; Noise, Audible

  IT WAS REPORTED THAT THE ROTAWIRE WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A ROTAWIRE AND WIRECLIP TORQUER (BX5) AND A 1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE FOOT PEDAL WAS STEPPED ON AND BEGAN TO ADVANCE THE BURR, IT WAS MAKING AN ABNORMAL SOUND. THE DEVICE WAS STOP AND PULLED BACK THE ROTAWIRE A BIT BUT THE END OF THE WIRE WAS NOT COMING BACK. THE PHYSICIAN ASSUMED THE WIRE WAS BROKEN APPROXIMATELY 20-30 CM FROM DISTAL END. THEY REMOVED THE PROXIMAL PORTION OF THE ROTAWIRE WHILE THE DISTAL PORTION REMAIN VISIBLE BEYOND THE ROTA DEVICE IN THE TIBIAL. WHEN THE ROTALINK PLUS WAS REMOVED, THE DISTAL WIRE CAME WITH IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066503 ↗
• MalfunctionJun 27, 2022Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT A DEVICE CONTAMINATION OCCURRED. A 1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. UPON RECEIPT OF THE PRODUCT, IT WAS NOTED THAT THERE WAS A PUNCTURE TO THE BOX AND IT COMPROMISED THE STERILITY OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14833564 ↗
• MalfunctionOct 11, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE WIRE WAS FRACTURED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND NOT VERY TORTUOUS STRAIGHT SEGMENT IN THE MID-DISTAL ANTERIOR TIBIAL. DURING THE PROCEDURE, RESISTANCE WAS FELT UPON ADVANCING AND IT WAS NOTED THAT THE WIRE FRACTURED INTO TWO PIECES. THE DEVICES WERE PULLED TOGETHER AND THE PHYSICIAN HAD TO RE-POSITION A NEW WIRE AND USED A WHOLE NEW DEVICE TO COMPLETE THE PROCEDURE. PER CLIENT, IT FELT THAT THE BREAK WAS ON ETHER ENTIRE TIME, DIFFICULT TO PASS OR RETRIEVE WIRE. THERE WAS NO INJURY REPORTED AND THE PATIENT IS SAFE, AND HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605989 ↗
• InjuryMar 25, 2021Entrapment of Device; Intermittent Loss of Power; Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT BURR STUCK IN LESION AND OPEN SURGERY WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT POSTERIOR TIBIAL ARTERY. A 1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, THE BURR WAS ADVANCED HOWEVER IT STALLED AND THE PATIENT WAS IN PAIN. THE DEVICE WAS THEN REMOVED BUT IT ONLY CAME BACK AT ABOUT 3-4CM BEFORE GETTING STUCK. ATTEMPTS WERE MADE TO REMOVE THE DEVICE BY USING DYNAGLIDE, MANUALLY PULLING BACK. THEY EVEN CUT THE BURR OFF THE ADVANCER AND USED 6FR GUIDE CATHETER TO DISLODGE THE BURR FROM THE VESSEL WALL BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS THEN STOPPED, PATIENT WAS TRANSFERRED TO THE NEARBY HOSPITAL AND HAD AN OPEN SURGERY. THE BURR WAS REMOVED AND THERE WERE PERFORATION SEEN AS IT WAS SURROUNDED BY THE INTIMAL WALL AND THE PATIENT WAS DOING WELL POST OPERATION. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 11569103 ↗
• MalfunctionFeb 22, 2021Entrapment of Device; Intermittent Loss of Power; Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY CALCIFIED DISTAL POST TIBIAL ARTERY. A 1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE ENTERED THE TARGET LESION AND STALLED OUT. IT WOULD NOT START SPINNING AGAIN AND WOULD NOT ADVANCE FORWARD OR BACKWARD WITH USE OF THE ADVANCER KNOB. IT WAS NOTED THAT THE BURR WAS STUCK IN THE LESION. THE PHYSICIAN PULLED THE ENTIRE CATHETER BACK AND THE DEVICE WAS FREED AND WAS ABLE TO SPIN AGAIN OUTSIDE THE PATIENT'S BODY. PHYSICIAN DID NOT RE-DELIVER THE DEVICE AS THE STENOSIS WAS TOO TIGHT AND CALCIFIED. IT WAS THEN TREATED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND THE PROCEDURE WAS COMPLETED WITHOUT PERFORMING ROTABLATION. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359197 ↗
• MalfunctionSep 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR WAS DETACHED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THERE WAS DIFFICULTY IN MANUALLY ADVANCING THE BURR TO THE PERONEAL. THE DEVICE WAS ACTIVATED VIA FOOT PEDAL AND ADVANCED WITH ROTATION. THE DEVICE WAS DEACTIVATED UPON REACHING THE INTENDED LOCATION AND THEN REACTIVATED FOR ABLATION. THE BURR WAS ATTEMPTED TO BE ADVANCED USING THE KNOB. WHEN THE KNOB WAS RETRACTED, THE BURR DID NOT RETRACT BACKWARDS WITH THE CATHETER AND THE BURR HAD BECOME DETACHED. THE WIRE AND ROTALINK SYSTEM WERE REMOVED TOGETHER. THE BURR CAME OUT INTACT ON THE WIRE; HOWEVER, IT WAS DETACHED FROM THE TIP OF THE CATHETER. NOTHING REMAINED BEHIND IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10505058 ↗
• MalfunctionAug 25, 2020Fluid/Blood Leak; Failure to Advance; Detachment of Device or Device Component; Fluid/Blood Leak; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CRACK/BREAK WAS NOTED. VASCULAR ACCESS WAS OBTAINED THROUGH THE LEFT POSTERIOR TIBIAL ARTERY. THE TARGET LESION AREA WAS LOCATED IN THE POPLITEAL ARTERY. A 1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DISTAL ROTA WIRE WAS PLACED IN THE LEFT ILIAC ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTA CATHETER WAS DIFFICULT TO ADVANCE THROUGH THE POPLITEAL ARTERY ALTHOUGH, IT RAN JUST FINE THROUGH THE POSTERIOR TIBIAL ARTERY AND THE TIBIOPERONEAL TRUNK. THE DEVICE WAS REMOVED AND SALINE/ROTAGLIDE SPRAYING OUT OF A CRACK IN THE CATHETER WAS NOTICED. HENCE, ROTA CATHETER HAD A CRACK/BREAK AT THE DISTAL END CLOSE TO THE BURR. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10449158 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED VESSEL PERFORATION. A 1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE IN THE POSTERIOR TIBIAL ARTERY. DURING ATHERECTOMY PROCEDURE, ANGIOGRAPHY SHOWED THAT A SMALL PERFORATION HAD OCCURRED. THE PHYSICIAN'S OPINION WITH THE CAUSE OF PERFORATION WAS THAT THE DEVICE WAS NOT ABLE TO HANDLE THE HIGH LEVEL DISEASE OF THE LESION. CONSEQUENTLY, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED AND THE PERFORATION WAS SEALED. THE PATIENT'S ARTERY WAS SUCCESSFULLY TREATED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FIND POST PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 10155141 ↗
• MalfunctionJun 1, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR SEIZED ON THE ROTAWIRE. VASCULAR ACCESS WAS VIA CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. A 1.50MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE ROTABURR SEIZED ON THE ROTAWIRE AND THE PHYSICIAN COULD NOT ADVANCE THE BURR. THE DEVICES WERE REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10105813 ↗
• MalfunctionMay 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE BURR DETACHED FROM THE CATHETER. A1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING PREPARATION, THE TIP OF THE BURR CAME OFF AND DETACHED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10087855 ↗
• MalfunctionJan 27, 2020Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device

  IT WAS REPORTED THAT THE WIRE BROKE OFF. THE TARGET LESION AREA WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE ALONG WITH A PERIPHERAL ROTAWIRE. DURING THE PROCEDURE, THE LESION WAS SO SEVERE THAT THE DEVICE FAILED TO ADVANCE. SUBSEQUENTLY, AFTER TWO ROTATIONAL RUNS OF ROTABLATOR, IT WAS NOTED THAT THE WIRE SNAPPED OFF AT THE END OF THE CATHETER AND PART OF IT REMAINED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS SENT FOR A PROCEDURE TO RETRIEVE DEVICE FRAGMENTS AND IT WAS SUCCESSFUL. THE PATIENT WAS STABLE AFTER THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE ROTAWIRE BROKE OFF DURING PREPARATION AND IT WAS NOT INSERTED INTO THE PATIENT. THE PATIENT WAS SENT TO THE HOSPITAL IN A NON-EMERGENT/OUT-PATIENT SETTING.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9632263 ↗
• MalfunctionJan 2, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR AND WIRE WERE STUCK. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY. A 1.50MM PERIPHERAL ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTAWIRE WAS STUCK AND THE BURR COULD NOT CUT THROUGH THE STENOSIS AND ENDED UP GETTING STUCK. THE DEVICES WERE PULLED OUT OF THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538460 ↗
• MalfunctionOct 31, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE WIRE. A 1.50MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BURR BECAME STUCK ON THE WIRE AND WOULD NOT ADVANCE. THE ROTALINK PLUS BURR WAS REMOVED WITH THE ROTAWIRE. THE PROCEDURE PROCEEDED WITH ANGIOPLASTY WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9262929 ↗
• MalfunctionAug 20, 2019Entrapment of Device; Mechanical Problem; Entrapment of Device; Mechanical Problem

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE GUIDE WIRE. A 1.50 MM PERIPHERAL ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR USE IN THE ANTERIOR TIBIAL. DURING THE PROCEDURE AFTER MOST OF THE PROCEDURE WAS COMPLETED, IT WAS NOTED THAT BURR STOPPED SPINNING ON THE ROTAWIRE AND BECAME STUCK ON THE ROTAWIRE. IT TOOK A LITTLE BIT OF TIME TO REMOVE FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910934 ↗
• MalfunctionJun 26, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE ROTAWIIRE. THE TARGET AREA WAS LOCATED IN THE LOWER RIGHT EXTREMITY. A 1.50MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE FOR AN ATHERECTOMY PROCEDURE. THE CATHETER WAS SUCCESSFULLY UTILIZED FOR THE MAJORITY OF THE DISEASED SEGMENT. A TOUCH UP FOR AN AREA WAS ATTEMPTED WHICH REQUIRED REVERSING THE DEVICE. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO MOVE THE BURR CATHETER BACKWARDS, THE CATHETER WOULD NOT TRACK BACKWARDS AND WAS STUCK ON THE ROTAWIRE. DYNAGLIDE MODE WAS ACTIVATED, BUT THE BURR CATHETER STILL WOULD NOT TRACK ON THE ROTAWIRE. CONSEQUENTLY, THE PHYSICIAN HAD TO CUT THE CATHETER AND REMOVED THE CATHETER AND WIRE TOGETHER. ROTAWIRE ACCESS WAS LOST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735373 ↗
• InjuryNov 1, 2018Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION AND ALSO BECAME STUCK WITH THE WIRE. ALSO, THE PATIENT EXPERIENCED PAIN AND VESSEL DISSECTION. THE HEAVILY CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT ANTERIOR TIBIAL ARTERY. A 1.50MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USED. DURING THE PROCEDURE, WHEN THE ROTABURR WAS ADVANCED, IT WAS NOTED THAT THE DEVICE BECAME STUCK IN THE VESSEL. THE PHYSICIAN BELIEVED THE BURR WRAPPED ON A DISSECTION FLAP. THE BURR ALSO BECAME BOUND TO THE WIRE AND THEREFORE THEY WERE REMOVED TOGETHER. HOWEVER, IT WAS FURTHER NOTED THAT THE PATIENT EXPERIENCED PAIN DURING THE REMOVAL OF THE DEVICES, AND A VESSEL DISSECTION OCCURRED IN THE PROXIMAL ANTERIOR TIBIAL ARTERY. THE DISSECTION WAS NOT FLOW LIMITING. THE CASE WAS ABORTED DUE TO THIS EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Intraoperative Pain; Pain; Vascular Dissection

  MAUDE report 8028818 ↗
• MalfunctionMay 31, 2017Contamination; Contamination

  IT WAS REPORTED THAT THE BURR CAUGHT THE DRAPE. A PERIPHERAL ROTALINK® PLUS WAS SELECTED FOR USE. DURING PREPARATION OUTSIDE PATIENT'S BODY, THE ROTATION OF THE DEVICE WAS TESTED. THE DEVICE MOVED AS THE PHYSICIAN TESTED THE RPMS. CONSEQUENTLY, IT WAS NOTICED THAT THE BURR BECAME CAUGHT ON THE BLUE TABLE DRAPE AND THE FOREIGN MATERIAL WRAPPED AROUND THE BURR. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6602301 ↗