Refinity ST Rotational IVUS Catheter 89900Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00845225002831), received between Jan 17, 2018 and Dec 10, 2025 — classified as 18 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K160583); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A REFINITY CATHETER WAS USED IN A CORONARY THERAPEUTIC PROCEDURE IN A MODERATELY CALCIFIED LAD. DURING PULLBACK, SLIGHT RESISTANCE WAS ENCOUNTERED, AND APPROX. 30 CM FROM THE DISTAL TIP SEPARATED. HOWEVER, THE SEPARATED PORTION REMAINED INTACT TO THE NON-PHILIPS GUIDEWIRE AND REMOVED ALL TOGETHER. THE PROCEDURE WAS COMPLETED WITH A NEW REFINITY CATHETER WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE REFINITY CATHETER SHAFT SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767765 ↗
• MalfunctionJun 4, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A REFINITY CATHETER WAS USED IN A CORONARY DIAGNOSTIC PROCEDURE. DURING USE, THE CATHETER WAS UNABLE TO BE REMOVED FROM THE PHILIPS GUIDEWIRE (3008363989-2025-00074) INDEPENDENTLY; THEREFORE, BOTH WERE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE REFINITY CATHETER AND PHILIPS GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142801 ↗
• InjuryJan 21, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A REFINITY CATHETER WAS USED IN A THERAPEUTIC CORONARY PROCEDURE IN A SEVERELY CALCIFIED LAD. PRIOR TO USE OF THE REFINITY, THE ARTERY WAS PRE-DILATED WITH A NON-COMPLIANT BALLOON. AFTER, THE REFINITY WAS ADVANCED OVER A WIGGLE WIRE; HOWEVER, DURING PULLBACK, THE CATHETER GOT STUCK IN THE LAD . ATTEMPTS TO REMOVE VIA MULTIPLE TECHNIQUES WERE UNSUCCESSFUL; THEREFORE, THE REFINITY WAS CUT FROM THE PIMR CONNECTION, AND A GUIDE LINER CATHETER WAS ADVANCED OVER THE REFINITY TO DISLODGE FROM THE ARTERY. THE PROCEDURE WAS COMPLETED WITH BALLOONING AND STENTING. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO ENTRAPMENT, REQUIRING ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200258 ↗
• MalfunctionNov 8, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT A REFINITY CATHETER WAS USED IN AN EMERGENT CORONARY DIAGNOSTIC PROCEDURE. DURING PULLBACK, THE CATHETER WAS RECOGNIZED BUT THE IMAGE DID NOT APPEAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER REFINITY CATHETER AND NO PATIENT INJURY WAS REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CATHETER COULD NOT BE USED DURING AN EMERGENT CASE; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646550 ↗
• MalfunctionJan 3, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A REFINITY CATHETER WAS USED IN A THERAPEUTIC CORONARY PROCEDURE IN THE MID CIRCUMFLEX ARTERY. PRIOR TO PATIENT USE, THE CATHETER WAS FLUSHED APPROPRIATELY PER THE IFU. NO AIR WAS OBSERVED AND IMAGING WAS ABLE TO BE COMPLETED. HOWEVER, UPON REMOVAL FROM THE PATIENT, AIR WAS PRESENT IN THE CATHETER. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED FOR THE AIR ENTRAPPED IN THE CATHETER. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441081 ↗
• MalfunctionAug 15, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS PRODUCT PROBLEM IS NO LONGER REPORTABLE BECAUSE NO AIR WAS SEEN ENTRAPPED IN THE DEVICE DURING THE RETURNED PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550881 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DIAGNOSTIC CORONARY PROCEDURE, THE REFINITY CATHETER WAS LOADED OVER A NON-PHILIPS GUIDEWIRE. DURING ADVANCEMENT IN THE LAD, A DISSECTION OCCURRED; HOWEVER, RESOLVED ITSELF WITHOUT STENT PLACEMENT. THE PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING, AND DISCHARGED AS EXPECTED. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE A DISSECTION OCCURRED. THERE WAS NO ALLEGED MALFUNCTION WITH THE REFINITY CATHETER.

  Patient problems: Vascular Dissection

  MAUDE report 15992245 ↗
• InjurySep 1, 2022No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE TO TREAT AN ELEVATED ST SEGMENT IN THE PATIENT''S LEFT ANTERIOR DESCENDING (LAD), A NON-MANUFACTURER''S BALLOON WAS USED FOR PRE-DILATATION TO ESTABLISH BLOOD FLOW FROM TIMI 0 TO TIMI 3. THEN, A REFINITY IVUS CATHETER WAS BEING PREPARED FOR USE, BUT DISPLAYED NO IMAGE. THE REFINITY WAS DISCONNECTED AND RECONNECTED, BUT STILL NO IMAGE. THEREFORE, A NEW REFINITY CATHETER WAS OPENED, BUT ALSO DISPLAYED NO IMAGE. AFTER APPROXIMATELY 15 MINS, AND WHILE ATTEMPTING TO USE THE SECOND REFINITY CATHETER, THE PATIENT COMPLAINED OF CHEST PAIN AND THE ECG SHOWED RE-ELEVATION OF THE ST SEGMENT. ANGIOGRAPHY SHOWED RE-OCCLUSION OF THE VESSEL. THE VESSEL WAS PRE-DILATED AND TIMI 3 FLOW WAS RE-ESTABLISHED. THE PROCEDURE WAS COMPLETED WITH A NON-MANUFACTURER¿S IVUS GUIDED STENT. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED TO CAPTURE THE SECOND MALFUNCTIONING REFINITY CATHETER (NOT USED IN PATIENT), WHICH DELAYED THE DIAGNOSIS AND RESULTED IN RE-OCCLUSION OF THE VESSEL, REQUIRING INTERVENTION.

  Patient problems: Chest Pain; Restenosis

  MAUDE report 15342429 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE TO TREAT AN ELEVATED ST SEGMENT IN THE PATIENT''S DISTAL LEFT CIRCUMFLEX ARTERY (LCX) DUE TO A THROMBOTIC OCCLUSION, A NON-MANUFACTURER''S BALLOON WAS USED FOR PRE-DILATATION TO ESTABLISH BLOOD FLOW FROM TIMI 0 TO TIMI 3. A STENT WAS PLACED ACROSS THE ARTERY, AND DUE TO ECTASIA OF THE PROXIMAL LCX, IT WAS DECIDED TO DO IVUS TO SECURE THE SIZE OF THE PROXIMAL PART OF THE STENT. A REFINITY IVUS CATHETER WAS BEING PREPARED FOR USE, BUT DISPLAYED NO IMAGE. THE REFINITY WAS DISCONNECTED AND RECONNECTED, BUT STILL NO IMAGE. A SECOND REFINITY CATHETER WAS OPENED, BUT ALSO DISPLAYED NO IMAGE, AND RE-ATTEMPTED CONNECTION WITHOUT SUCCESS. THEREFORE, A THIRD REFINITY CATHETER WAS OPENED AND EXPERIENCED THE SAME FAILURE. FINALLY, A FOURTH REFINITY CATHETER WAS OPENED AND WAS ABLE TO BE USED; HOWEVER, THE OVERALL ATTEMPT TO PERFORM IVUS DELAYED THE PROCEDURE APPROXIMATELY 15 MINUTES. THE PATIENT COMPLAINED OF CHEST PAIN AND ANGIOGRAPHY SHOWED A DISTAL EMBOLUS (CAUSE UNKNOWN) TO THE DISTAL LCX, AND THROMBECTOMY WAS PERFORMED TO RE-ESTABLISH BLOOD FLOW FROM TIMI 0/1 TO TIMI 3. THIS ADVERSE EVENT IS BEING SUBMITTED TO CAPTURE THE FOURTH REFINITY CAT

  Patient problems: Chest Pain; Embolism/Embolus

  MAUDE report 15342428 ↗
• InjurySep 1, 2022No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE TO TREAT AN ELEVATED ST SEGMENT IN THE PATIENT''S LEFT ANTERIOR DESCENDING (LAD), A NON-MANUFACTURER''S BALLOON WAS USED FOR PRE-DILATATION TO ESTABLISH BLOOD FLOW FROM TIMI 0 TO TIMI 3. THEN, A REFINITY IVUS CATHETER WAS BEING PREPARED FOR USE TO MEASURE THE DIAMETER OF THE VESSEL FOR STENT PLACEMENT, BUT DISPLAYED NO IMAGE. THE REFINITY WAS DISCONNECTED AND RECONNECTED, BUT STILL NO IMAGE. A SECOND REFINITY CATHETER WAS OPENED, BUT ALSO DISPLAYED NO IMAGE, AND RE-ATTEMPTED CONNECTION WITHOUT SUCCESS. THEREFORE, A THIRD REFINITY CATHETER WAS OPENED AND EXPERIENCED THE SAME FAILURE. AFTER APPROXIMATELY 15 MINS, AND WHILE ATTEMPTING TO USE THE THIRD REFINITY CATHETER, THE PATIENT COMPLAINED OF CHEST PAIN AND THE ECG SHOWED RE-ELEVATION OF THE ST SEGMENT. ANGIOGRAPHY SHOWED RE-OCCLUSION OF THE VESSEL. THE VESSEL WAS PRE-DILATED AND TIMI 3 FLOW WAS RE-ESTABLISHED. THE PROCEDURE WAS COMPLETED WITH A NON-MANUFACTURER¿S IVUS GUIDED STENT. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED TO CAPTURE THE THIRD MALFUNCTIONING REFINITY CATHETER (NOT USED IN PATIENT), WHICH DELAYED THE DIAGNOSIS AND RESULTED IN RE-OCCLUSION OF THE VESSE

  Patient problems: Chest Pain; Restenosis

  MAUDE report 15342427 ↗
• MalfunctionJun 30, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A CORONARY DIAGNOSTIC PROCEDURE IN A SEVERELY CALCIFIED MID RCA, THE REFINITY CATHETER WAS DELIVERED OVER A NON-MANUFACTURER GUIDE WIRE. DURING USE, THE PHYSICIAN STRUGGLED TO MAINTAIN GUIDE ENGAGEMENT THROUGHOUT THE PROCEDURE. FOLLOWING THE SECOND SUCCESSFUL IVUS RUN PRE-PCI, THE PHYSICIAN WAS UNABLE TO REMOVE THE CATHETER, THUS WAS REMOVED WITH THE GUIDE CATHETER AND GUIDE WIRE AT THE SAME TIME. UPON REMOVAL, IT WAS NOTED THAT THE GUIDE WIRE WAS EXTENSIVELY BENT AND ASSUMED THE REASON FOR THE INABILITY IN TRYING TO REMOVE THE CATHETER OFF THE WIRE INSIDE THE VESSEL. THE PROCEDURE WAS COMPLETED WITH A NEW REFINITY CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE REFINITY CATHETER REMOVED AS A SYSTEM AND CAN RESULT IN A POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880874 ↗
• MalfunctionDec 9, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED DURING A THERAPEUTIC CORONARY PROCEDURE, THAT DURING PREPARATION FOR USE, THE MANUFACTURER'S CATHETER WAS FLUSHED MULTIPLE TIMES WITH A LOT OF RESISTANCE ENCOUNTERED. HOWEVER, THE DEVICE WAS USED IN THE PATIENT, AND DURING PULLBACK, THE IMAGES SHOWED AIR ENTRAPPED IN THE CATHETER. A SECOND MANUFACTURER'S CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED FOR THE AIR ENTRAPPED IN THE CATHETER. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12969068 ↗
• MalfunctionDec 9, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED DURING A THERAPEUTIC CORONARY PROCEDURE, THAT DURING PREPARATION FOR USE, THE MANUFACTURER'S CATHETER WAS FLUSHED MULTIPLE TIMES WITH A LOT OF RESISTANCE ENCOUNTERED. HOWEVER, THE DEVICE WAS USED IN THE PATIENT, AND DURING PULLBACK, THE IMAGES SHOWED AIR ENTRAPPED IN THE CATHETER. A SECOND MANUFACTURER'S CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED FOR THE AIR ENTRAPPED IN THE CATHETER. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12969035 ↗
• InjuryAug 5, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A THERAPEUTIC CORONARY PROCEDURE INSIDE THE BODY DURING PULLBACK, THE MANUFACTURER'S CATHETER GOT STUCK TO THE NON-MANUFACTURER'S STENT IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED MID LCX AND COULD NOT BE RETRIEVED. THE SHAFT WAS CUT FOR BAIL-OUT PURPOSE, AND AFTER IMAGING CORE WAS REMOVED, A 0.025 WIRE WAS INTRODUCED BUT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGICAL INTERVENTION AND REPORTEDLY RECOVERING. THE PHYSICIAN STATED THE ADVERSE EVENT WAS NOT CAUSED BY THE MANUFACTURER'S CATHETER. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PATIENT REQUIRED SURGICAL INTERVENTION TO RETRIEVE THE MANUFACTURER'S CATHETER THAT GOT STUCK TO THE NON-MANUFACTURER''S STENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12281275 ↗
• MalfunctionJul 16, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE, INSIDE THE BODY DURING THE SECOND PULLBACK, THE MANUFACTURER'S CATHETER GOT STUCK ON THE NON-MANUFACTURER'S'S GUIDEWIRE, THUS THE WIRE AND CATHETER WERE REMOVED TOGETHER AS A SYSTEM. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE MANUFACTURER'S CATHETER BECAME STUCK ON THE NON-MANUFACTURER'S GUIDEWIRE AND WERE REMOVED AS A SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12183819 ↗
• InjuryMay 28, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE INSIDE THE BODY WHILE ADVANCING TO THE MID RCA, THE MANUFACTURER'S CATHETER WAS LOADED ONTO THE NON-MANUFACTURER'S'S GUIDE WIRE WITH NO RESISTANCE NOTED. THE CATHETER WAS TURNED ON AND AT FIRST DISPLAYED NO IMAGE. ON THE ANGIOGRAM, IT DID NOT APPEAR THAT ANYTHING LOOKED DIFFERENT. HOWEVER, UPON REMOVAL, THE GUIDE WIRE WAS WRAPPED/ ENTANGLED AROUND THE CATHETER. AS A RESULT, A SMALL MYOCARDIAL PERFORATION WAS NOTED, BUT NO STENT WAS PLACED. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. THE PATIENT WAS AMBULATED AND AFTER A COUPLE OF HOURS OF NO CHEST PAIN, THE PATIENT WAS DISCHARGED HOME AT THE END OF THE DAY. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE PATIENT EXPERIENCED A PERFORATION AND REQUIRED HOSPITALIZATION. IN ADDITION, THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE MANUFACTURER'S CATHETER BECAME ENTANGLED AROUND THE NON-MANUFACTURER'S'S GUIDE WIRE AND WERE REMOVED AS A UNIT.

  Patient problems: Perforation of Vessels

  MAUDE report 11905480 ↗
• MalfunctionApr 26, 2021Entrapment of Device; Entrapment of Device

  THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE MANUFACTURERS DEVICE AND ANOTHER MANUFACTURERS DEVICE WERE REMOVED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724058 ↗
• InjuryAug 31, 2020Entrapment of Device; Entrapment of Device

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO CORRECT AN INADVERTENT ENTRY ERROR IN G4, THE DATE RECEIVED BY MANUFACTURER (BECOMES AWARE DATE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10472326 ↗
• InjuryMay 28, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED DURING A THERAPEUTIC CORONARY PROCEDURE THE MANUFACTURER¿S CATHETER DEVICE GOT STUCK ON A CALCIFIED LESION AND COULD NOT BE REMOVED. THE TARGET LESION WAS LAD [LEFT ANTERIOR DESCENDING ARTERY] WITH SEVERE CALCIFICATION AND TORTUOSITY. WHILE THE MANUFACTURER¿S CATHETER DEVICE WAS MANIPULATED TO CONFIRM STENT LANDING, THE TIP OF THE DEVICE GOT STUCK ON A CALCIFIED LESION. ANOTHER MANUFACTURER¿S WIRE DEVICE WAS INSERTED AS A BUDDY-WIRE, A GUIDELINER WAS INSERTED BUT ONLY REACHED PROXIMALLY DUE TO CALCIUM. THE TELESCOPE SHAFT OF THE MANUFACTURER¿S CATHETER DEVICE WAS CUT AND THE TRANSDUCER REMOVED. ANOTHER MANUFACTURER¿S WIRE DEVICE WAS INSERTED INTO THE MANUFACTURER¿S CATHETER DEVICE, FREEING IT FOR REMOVAL. THE 2 WIRES AND THE MANUFACTURER¿S CATHETER DEVICE WERE REMOVED TOGETHER. NO PORTION OF THE DEVICE WAS LEFT IN THE PATIENT AND NO INJURY WAS REPORTED. THE PROCEDURE WAS CONTINUED AND A BALLOON WAS USED TO DILATE THE LAD, AS PLANNED. 2 STENTS WERE IMPLANTED. FINALLY, IFR WAS USED TO EVALUATE. ANOTHER SCHEDULED RCA PROCEDURE WAS ALSO COMPLETED WITH IFR ASSESSMENT. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE MANUFAC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10098372 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO CORRECT AN INADVERTENT ENTRY ERROR IN G4, THE DATE RECEIVED BY MANUFACTURER (BECOMES AWARE DATE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9941709 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO ADVISE PERTINENT DEVICE ANALYSIS FINDINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8888474 ↗
• InjuryMay 2, 2019Material Separation; Material Separation

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO ADVISE PERTINENT DEVICE ANALYSIS FINDINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8576247 ↗
• InjuryJan 10, 2019Off-Label Use; Off-Label Use

  THIS FOLLOW-UP SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE DEVICE ANALYSIS ON THE SUBJECT DEVICE RETURNED TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8234317 ↗
• MalfunctionAug 28, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS INITIALLY REPORTED THE IMAGE DISAPPEARED ON THE MANUFACTURER'S DEVICE. A SECOND OF THE SAME MAKE AND MODEL OF THE MANUFACTURER'S DEVICE WAS USED TO SUCCESSFULLY IMAGE THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO PATIENT INJURY AND NO ADVERSE EVENTS. THE DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. IT WAS OBSERVED THAT THERE WERE KINKS AND BENDS ALONG THE PROXIMAL SHAFT OF THE DEVICE. THE BRAIDED SHAFT WAS EXPOSED BUT STILL INTACT. NO SHARP EDGES WERE PROTRUDING AND NO SANGUINEOUS MATERIAL WAS PRESENT. THE EXTENSION SHAFT WAS SEPARATED FROM THE DRIVE CABLE IN THE LUER LOCK AREA OF THE CONNECTOR ASSEMBLY. THE REPORTED FAILURE (INCOMPLETE IMAGE) COULD NOT BE DUPLICATED. THE PROBABLE CAUSE OF THE REPORTED FAILURE IS DUE TO THE OBSERVED KINKS AND SHAFT SEPARATION ON THE RETURNED DEVICE. IT COULD NOT BE DETERMINED WHEN THE OBSERVED DAMAGE OCCURRED. THE PROBABLE CAUSE OF THE OBSERVED FAILURE (EXPOSED BRAIDED SHAFT) COULD NOT BE DETERMINED. THE USER REPORTED NO DAMAGE WAS OBSERVED ON THE DEVICE AFTER REMOVAL AND WHEN PREPARING THE DEVICE FOR RETURN. THE DEVICE INTEGRITY CAN BE AFFECTED BY EXTERNAL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7825492 ↗
• InjuryJul 18, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, INSIDE THE BODY, WHILE PASSING THROUGH THE LESION AT BIFURCATION OF LEFT CIRCUMFLEX ARTERY (LCX #12), THE USER WAS UNABLE TO MOVE THE MANUFACTURER'S DEVICE OVER THE GUIDEWIRE (ANOTHER MANUFACTURER'S DEVICE). THE MANUFACTURER'S DEVICE WAS REMOVED WITH THE GUIDEWIRE. ACCESS LOCATION: FEMORAL, VESSEL TORTUOSITY: SEVERE. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS EVENT IS BEING REPORTED BECAUSE THE MANUFACTURES DEVICE AND ANOTHER MANUFACTURER'S DEVICE (GUIDEWIRE) WERE REMOVED AS A SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7701029 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160583. One submission often covers many models, so check the product and lot details in each record.

• Z-1776-2017 · Mar 29, 2017 · Terminated
  Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: The REFINITY (or REFINITY ST) Rotatio
• Z-1775-2017 · Mar 29, 2017 · Terminated
  Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS C