Peripheral RotaLink® Plus M0011401750Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729838913), received between Jan 2, 2019 and Dec 10, 2020 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE ROTABURR BECAME STUCK IN THE ROTAWIRE. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL VESSEL. A 1.75MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT BOTH DEVICE BECAME STUCK TOGETHER INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. NO NEGATIVE SEQUELAE OCCURRED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10985497 ↗
• InjuryMar 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR AND ROTAWIRE DETACHED AND WAS LEFT INSIDE PATIENT'S BODY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR TIBIAL VESSEL. A 1.75MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, ATHERECTOMY GOT THROUGH THE LESION. HOWEVER, WHEN THE 1.75MM PERIPHERAL ROTALINK PLUS WAS TAKEN OUT, IT WAS NOTED THAT THE BURR HEAD WAS NOT MOVING. AFTER RETRACTING THE ENTIRE CATHETER, THE BURR HEAD IS STILL INSIDE. THEN, WHEN THE ROTAWIRE WAS TAKEN OUT, THE PHYSICIAN FURTHER NOTED THAT A PIECE OF THE WIRE AND THE BURR HEAD WERE LEFT INSIDE THE PATIENT. CONSEQUENTLY, THE PHYSICIAN TRIED TO SNARE THE FRAGMENTS OUT; HOWEVER, IT WAS UNABLE TO BE SNARED SO THE PHYSICIAN COMPLETED THE PROCEDURE TO MAKE SURE THE PATIENT STILL HAD RUNOFF IN THE FOOT AND THEY WERE DONE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PHYSICIAN TALKED WITH THE PATIENT AND THEY MAY HAVE TO TAKE HIM TO SURGERY TO TAKE IT OUT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9781374 ↗
• MalfunctionJan 27, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR STUCK ON WIRE. THE TARGET LESION WAS LOCATED IN THE RIGHT ANTERIOR TIBIAL ARTERY DOWN IN THE LEG. A 1.75MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BURR STUCK ON THE WIRE UPON SPINNING. THE DEVICES WERE PULLED OUT TOGETHER OUT OF THE PATIENT'S BODY AS THE BURR COULD NOT BE REMOVE OVER THE WIRE. REWIRING WAS DONE AND THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY, END RESULT WAS GREAT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9633110 ↗
• MalfunctionJan 16, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR LOCKED ON TO THE WIRE. THE 85% STENOSED TARGET LESION AREA WAS LOCATED IN A SEVERELY CALCIFIED PERONEAL ARTERY ON THE LEG. A 1.75MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE TOGETHER WITH A ROTAWIRE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR GOT STUCK ON THE WIRE AND STOPPED SPINNING. THE DEVICE WAS COMPLETELY REMOVED TOGETHER WITH THE WIRE. HOWEVER, THEY NEED TO REGAIN WIRE ACCESS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS EXCELLENT POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9595818 ↗
• MalfunctionDec 13, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR STUCK WITH THE WIRE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY. A 1.75MM PERIPHERAL ROTALINK PLUS WAS USED TOGETHER WITH A ROTAWIRE. DURING PROCEDURE, IT WAS NOTED THAT THE BURR WAS STUCK WITH THE WIRE. THE PROCEDURE WAS COMPLETED WITH A NEW 1.75MM BURR AND WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468851 ↗
• MalfunctionNov 5, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE GOT STUCK ON THE WIRE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR TIBIAL ARTERY. A 1.75 PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WAS SELECTED FOR USE. THE VESSEL WAS PRE-DILATED FIRST WITH A 2.5MM X 220MM COYOTE BALLOON. DURING THE PROCEDURE, IT WAS NOTED THAT A 1.75MM PERIPHERAL ROTALINK PLUS WAS SPINNING WHEN IT GOT STUCK ON THE ROTAWIRE. DIFFICULTY IN ADVANCING THE CATHETER WAS ENCOUNTERED AS IT WAS STUCK TO THE WIRE, SO THE ROTALINK BURR WAS REMOVED TOGETHER WITH THE ROTAWIRE WITH NO DIFFICULTIES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280791 ↗
• InjuryMay 9, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE TARGET LESION WAS LOCATED IN THE RIGHT ANTERIOR TIBIAL ARTERY. A 1.75MM PERIPHERAL ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS STUCK IN THE VESSEL. HOWEVER, THE BURR AND THE WIRE WERE RETRIEVED BY ACCESSING FROM A PEDAL PUSHING THE BURR WITH A MICRO CATHETER WHILE SIMULTANEOUSLY RETROGRADING AT THE SAME TIME. SUBSEQUENTLY, THE BURR AND THE WIRE WERE REMOVED INTACT. THE PROCEDURE WAS COMPLETED USING BALLOON ANGIOPLASTY WITH NO NEW ROTA WAS USED. PATIENT WAS NOT INJURED AND NO COMPLICATIONS REPORTED. PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596028 ↗
• MalfunctionMar 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR DISCONNECTED FROM THE SHAFT. THE TARGET LESION WAS LOCATED IN THE LEFT TIBIAL-PERONEAL TRUNK. A 1.75MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BURR DISCONNECTED FROM THE DRIVE SHAFT. CONSEQUENTLY, THE BURR WAS PULLED OUT WITH THE WIRE AND THEN THE VESSEL WAS RE-WIRED AND BALLOONED WITH AN ANGIOPLASTY BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8451737 ↗
• InjuryJan 2, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BURR BROKE OFF AND THE PATIENT EXPERIENCED A SMALL PERFORATION. THE 60MM TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT PERONEAL ARTERY. A 1.75MM PERIPHERAL ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, AFTER TREATING APPROXIMATELY 20MM OF THE HEAVILY CALCIFIED PERONEAL ARTERY, IT WAS NOTED THAT THE BURR BROKE OFF. THE PHYSICIAN WAS ABLE TO REMOVE THE ROTAWIRE WITH THE BURR STILL ENTRAPPED ON THE WIRE. CONSEQUENTLY, THE PATIENT HAD A SMALL PERFORATION IN THE OCCLUDED SEGMENT OF THE PERONEAL ARTERY DURING WITHDRAWAL. THE PERONEAL ARTERY WAS NO LONGER POSSIBLE TO CANNULATE. THE PROCEDURE WAS UNSUCCESSFUL. NO OTHER DEVICES WERE USED AFTER BECAUSE THEY WERE UNABLE TO GET A WIRE BACK DOWN ACROSS THE DISEASED SEGMENT OF THE ARTERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 8208533 ↗