RotaLink™ Plus H749236310150Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729316473), received between Nov 16, 2016 and Nov 21, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (5 reports).

4 other recalls cover devices cleared under the same FDA submission (P900056); they may or may not involve this specific model.

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.

• MalfunctionNov 21, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 2.15MM ROTABLATOR ROTALINK PLUS AND A ROTAWIRE DRIVE WERE SELECTED FOR USE. THE ROTABLATOR WAS PREPARED OUTSIDE THE BODY AND PLATFORMED AT 180,000RPM. DURING INSERTION, IT WAS NOTED THAT THE BURR WAS STUCK WITH THE ROTAWIRE. THERE WAS RESISTANCE ENCOUNTERED BETWEEN THE BURR AND ROTAWIRE. THE BURR AND THE ROTAWIRE WERE REMOVED TOGETHER AS ONE UNIT FROM THE PATIENT. AFTER REMOVING THE DEVICES FROM THE PATIENT'S BODY, DAMAGE WAS NOTED TO THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT DEVICES. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834796 ↗
• MalfunctionJul 19, 2019Detachment of Device or Device Component; Material Deformation; Noise, Audible; Detachment of Device or Device Component; Material Deformation; Noise, Audible

  IT WAS REPORTED THAT THE BASE OF THE BURR WAS DETACHED. THE 75% STENOSED TARGET LESION AREA WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. A 2.15MM ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, THE NON-BSC STENT WHICH WAS PLACED IN THE CIRCUMFLEX ARTERY FROM THE LEFT MAIN TRUNK IN THE PAST WAS FRACTURED IN THE TORTUOUS PART OF THE CX OS. SUBSEQUENLTY, ABLATION WAS PERFORMED WITH THIS DEVICE UPON RESTENOSIS CASE WITH SEVERE CALCIFICATION. ABLATION TIME WAS 6 SESSIONS FOR 15 SECONDS EACH, THEN POBA WAS PERFORMED USING A NON-SPECIFIED 2.0MM BALLOON CATHETER. ADDITIONALLY, THERE WERE 9 SESSIONS FOR 15 SECONDS EACH PERFORMED WITH THIS DEVICE. HOWEVER, UPON THE NINTH SESSION, ABNORMAL SOUND WAS HEARD. THE KNOB OF THIS DEVICE WAS MANIPULATED BUT IT WAS FURTHER NOTED THAT THE BURR DID NOT MOVED AS THE ROTATIONAL BURR GOT DETACHED FROM THE DRIVESHAFT ON THE ROTAWIRE. THE DETACHED BURR WAS THEN REMOVED TOGETHER WITH THE ROTAWIRE UNDER A GUIDEZILLA SUPPORT SINCE THE WIRE WAS NOT BROKEN. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. ALSO, THE MAXIMUM BURR ROTATIONAL SPEED DECREASE AT 15,000RPM DURING PROCEDURE AND AT 5,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808280 ↗
• MalfunctionOct 19, 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 TO THE WIRE. A STENOSED TARGET LESION WAS LOCATED AT SEVERELY CALCIFIED CORONARY ARTERY. A 2.15MM ROTALINK PLUS AND ROTAWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BURR GOT STUCK ON THE WIRE DURING REMOVAL ATTEMPTS. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7984895 ↗
• MalfunctionNov 7, 2017Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED THAT THE SEAL WAS OPENED. A 2.15MM ROTALINK¿ PLUS WAS SELECTED TO BE USED; HOWEVER, THE SEAL OF THE DEVICE WAS FOUND TO BE OPENED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7007888 ↗
• MalfunctionAug 4, 2017Entrapment of Device; Entrapment of Device

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME BURR CATHETER AND ANOTHER OF THE SAME ROTAWIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6767276 ↗
• MalfunctionMay 4, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR ID: 2134265-2017-04741. IT WAS REPORTED THAT THE BURR BECAME STUCK ON WIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 2.15MM ROTALINK¿ PLUS AND ROTAWIRE¿ WERE SELECTED FOR USE. DURING PROCEDURE, AFTER A NON BSC GUIDEWIRE WAS PASSED THROUGH THE TARGET LESION, THE ROTAWIRE¿ WAS PLACED INTO THE RCA. THE 2.15MM BURR WAS THEN INSERTED AND ADVANCED; HOWEVER, IT FAILED TO CROSS THE LESION. THE PHYSICIAN EXCHANGED THE BURR WITH A SMALLER SIZE AND WAS USED SUCCESSFULLY TO TREAT THE LESION. THE 2.15MM ROTALINK¿ PLUS WAS THEN ADVANCED AGAIN BUT STILL FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS WITHDRAWN, RESISTANCE WAS ENCOUNTERED AND THE BURR BECAME STUCK ON THE WIRE. THE PHYSICIAN THEN REMOVED IT AS A SYSTEM AND WAS NOT ABLE TO SEPARATE WIRE AND THE BURR OUTSIDE THE PATIENT¿S BODY. A NON BSC BALLOON CATHETER WAS USED TO DILATE THE TARGET LESION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6545386 ↗
• MalfunctionApr 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON DEVICE ANALYSIS OF THE RELATED COMPLAINT COMPLETED ON 31 MARCH 2017. SAME CASE AS MDR ID: 2134265-2017-03706. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED AND THE BURR DID NOT ROTATE. A 330CM ROTAWIRE¿ AND A ROTALINK¿ PLUS WERE SELECTED FOR USE. DURING PREPARATION, THE BURR HAD MET RESISTANCE AGAINST THE WIRE AND IT DID NOT ROTATE DUE TO FRICTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS OF THE RELATED COMPLAINT REVEALED THAT THE ROTAWIRE WAS FRACTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6515792 ↗
• InjuryJan 30, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN LESION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.15MM ROTALINK¿ PLUS WAS SELECTED TO BE USED. ABLATIONS WERE PERFORMED 180,000 RPM FOR 20 TO 25 SECONDS EACH WITH THE BURR MOVING BACK AND FORTH CONSTANTLY. AFTER THE SECOND ABLATION, A SPACE IN THE LESION WAS NOTED AND THE BURR BECAME STUCK ON THE SPACE OF THE LESION. THE OUTER SHEATH WAS REMOVED AND RETRIEVAL WAS SUCCESSFULLY PERFORMED USING A NON BSC CATHETER WITHOUT ANY PATIENT INJURY. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6285756 ↗
• MalfunctionNov 16, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.75MM ROTALINK BURR WAS USED AND THEN THE PHYSICIAN SELECTED A 2.15MM ROTALINK PLUS FOR USE. DURING PREPARATION OF THE DEVICE IT WAS NOTED THAT THE HANDSHAKE CONNECTION WAS DISCONNECTED. THE HANDSHAKE WAS MANUALLY CONNECTED AND THE DEVICE ADVANCED TO THE LESION FOR USE. DURING USE, THERE WAS A SUDDEN INCREASE OF SPEED FROM 220,000RPM TO 300,000RPM. THE CATHETER WAS REMOVED FROM THE PATIENT TO INSPECT THE HANDSHAKE CONNECTION AND IT WAS OBSERVED THAT THE DRIVE SHAFT CONNECTOR PORTION WAS MISSING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6108365 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P900056. One submission often covers many models, so check the product and lot details in each record.

• Z-0916-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
• Z-0915-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
• Z-0211-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator
• Z-0212-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rota