NIRxcell CoCr Coronary Stent on RX System NXL35033USRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290107010993), received between Nov 23, 2015 and Oct 3, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "THE STENT CAME OFF OF THE COVER AND THIS IS THE SECOND ONE THAT HAS OCCURRED IN 4 MONTHS." ADDITIONAL INFORMATION RECEIVED: FROM CORDIS (SEPTEMBER 10, 2018): VESSEL / LESION CHARACTERISTICS: IT IS UNKNOWN WHETHER THE LESION WAS CALCIFIED. IT IS UNKNOWN WHETHER THERE WAS VESSEL TORTUOSITY. IT IS UNKNOWN WHETHER THERE WAS VESSEL ANGULATION . THE DEVICE WAS NOT USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING. COMPONENTS: THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED: WHEN PULLING THE CAP OFF TO PREP THE STENT THE ACTUAL STENT CAME OFF THE BALLOON AND WAS STUCK INSIDE THE CAP. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING REMOVAL OF THE DEVICE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS NOT CLINICALLY USED. THE DEVICE WAS NEVER PUT IN PATIENT. THERE WAS SO PATIENT INJURY. FROM CORDIS (SEPTEMBER 12, 2018): TRACKING NUMBER FOR THE DEVICE WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7929276 ↗
• MalfunctionOct 13, 2016Difficult to Remove; Device Dislodged or Dislocated; Failure To Unwrap; Difficult to Remove; Device Dislodged or Dislocated; Failure To Unwrap

  REPORTED ON SEPTEMBER 20, 2016: SHORT DESCRIPTION: NO CROSS THERE WAS A TRACKING DIFFICULTY AND PROBLEM CROSSING THE LESION. THE PROCEDURE WAS COMPLETED WITH MEDTRONIC PRODUCT. DE NOVO. THE LESION HAD HIGH CALCIFICATION AND THE VESSEL MEDIUM CALCIFICATION. PRE DILATATION WAS PERFORMED. TIMI FLOW POST PROCEDURE 3. THERE WAS NO HARM / INJURY TO THE PATIENT. UPDATED COMPLAINT INFORMATION RECEIVED ON SEP. 21, 2016: DOCTOR'S NAME, OCCURRENCE DATE, AND COMPLAINT DESCRIPTION HAVE BEEN UPDATED. DESCRIPTION: 'PROTECTIVE SLEEVE/SHIPPING MANDREL REMOVAL DIFFICULTY; STENT UN-CRIMPED ON BALLOON (OUTSIDE PATIENT)' INSTANT RE-STENOSIS OF PROXIMAL MID RCA AND MID RCA LESION, NO DE NOVO. 85% STENOSIS, VESSEL CLASSIFICATION HIGH. NO PRE DILATION WAS PERFORMED. PRE AND POST PROCEDURE TIMI FLOW 3. "UPON PREPPING ONE OF THE STENTS THE PLASTIC-STENT STYLUS WAS DIFFICULT TO REMOVE THEREFORE THE TECH USED FORCE TO REMOVE AND THE PHYSICIAN FELT UNCOMFORTABLE PUTTING THE STENT IN THE PATIENT. DUE TO THE EXCESS FORCE USED HE FELT THERE MIGHT BE A STENT RETENTION ISSUE. DURING THE SECOND STENT PREPPING THE TECH EXPERIENCED THE SAME DIFFICULTY REMOVING THE PLASTIC COVERING BUT WAS ABLE TO FINALLY REMOVE. DR. (

  Patient problems: No Known Impact Or Consequence To Patient; Stenosis

  MAUDE report 6025460 ↗
• MalfunctionMar 14, 2016Material Deformation; Material Deformation

  EVENT OCCURRED DURING POST MARKET CLINICAL STUDY, (B)(4). DESCRIPTION PROVIDED VIA E-MAIL FROM (B)(6) ON (B)(6) 2016. (B)(6) REPORTED THAT THEY ENROLLED SUBJECT (B)(6) TODAY. THIS WAS A SINGLE VESSEL LESION, NO STENT COMPLICATIONS WERE ANTICIPATED, AND A NON-STUDY STENT(S) WAS USED TO TREAT THE TARGET LESION. THEY WERE ABLE TO WITHDRAW THE STENT AND THE PRODUCT WILL BE RETURNED TO MEDINOL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2016:THE STUDY COORDINATOR (SC) REPORTED THE FOLLOWING: THE NIRXCELL STENT WOULD NOT CROSS THE LESION, WHEN THE OPERATOR BROUGHT THE STENT BACK INTO THE GUIDE CATHETER, SOME OF THE STENT STRUTS BECAME RAISED DURING PULLBACK. THE PRINCIPAL INVESTIGATOR (PI) WAS ABLE TO GET STENT BACK INTO THE GUIDING CATHETER AND REMOVE IT FROM THE SUBJECT. THE EVENT WAS INITIALLY INADVERTENTLY REPORTED AS SAE, BUT IT IS NOT AE OR SAE. ADDITIONAL INFORMATION RECEIVED ON (B)(4 2016: DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), THE NIRXCELL STENT WOULD NOT CROSS THE LESION. THE STENT WAS THEN BEING BROUGHT BACK INTO THE DELIVERY SYSTEM/GUIDE CATHETER AND SOME OF THE STENT STRUTS BEGAN TO RAISE DURING THE PULLBACK. THE PI WAS ABLE TO GET THE STENT BACK INTO THE GUIDE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5497698 ↗
• MalfunctionNov 23, 2015Inflation Problem; Leak/Splash

  IT WAS REPORTED FROM (B)(6) CLINIC IN (B)(6), THAT DURING THE PROCEDURE PERFORMED WITH NIRXCELL CORONARY STENT SYSTEM, CATALOGUE #NXL35033US, TYPE 3.5X33MM, FROM LOT # NUS00163, "DR. (B)(6) INSERTED THE DEVICE IN THE PATIENT WITH NO ISSUES AND WHEN TRIED INFLATING THE PTCA THE PTCA WOULD NOT INFLATE TO PROPER PRESSURE LEVEL. DR. (B)(6) REMOVED AND USED ANOTHER WIRE AND WAS ABLE TO INFLATE THE PTCA. PATIENT'S CONDITION AFTER WAS GOOD. POST ANGIO'S WERE GOOD. THERE WAS NO ADVERSE EVENTS". ADDITIONAL DATA: INFORMATION RECEIVED ON (B)(6) 2015 FROM (B)(6): THE USER WAS TRAINED ON THE DEVICE. THE PROBLEM OCCURRED DURING USE IN THE PATIENT. THE EVENT IS NOT RELATED TO THE STENT. THE EVENT IS RELATED TO THE BALLOON. THERE WAS A PROBLEM INFLATING THE BALLOON. THERE WAS NO INJURY AND THE CONDITION OF PATIENT AFTER THE PROCEDURE WAS GOOD. INFORMATION RECEIVED ON (B)(6) 2015 FROM MEDINOL'S MARKETING DEPT.: "THE NIRXCELL SYSTEM WAS USED FOR STENTING OF THE POSTERIOR TIBIAL ARTERY (LEG ARTERY BELOW THE KNEE). WHEN PREPARING THE SYSTEM THE SHIPPING MANDREL WAS DIFFICULT TO REMOVE, SO THE PHYSICIAN USED A HEMOSTAT TO REMOVE THE MANDREL; HE LOCKED THE HEMOSTAT TO THE PROTECTIVE SLEEVE DISTAL TO THE

  Patient problems: No Information

  MAUDE report 5270458 ↗