NanoCross EliteRecalls & reported problems across all models
Medtronic, Inc. · 31 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one NanoCross Elite model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 1
We found 31 models of NanoCross Elite by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Aug 6, 2024 and Sep 30, 2026 — classified as 18 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (26 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
NanoCross Elite recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 10, 2024Class IIOpen, Classified
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Z-0904-2025 · Root cause: Process change control · names 19 of these models · Recall details · FDA record ↗
Most reported NanoCross Elite problems
Device problems
- Deflation Problem26
- Burst Container or Vessel16
- Detachment of Device or Device Component8
- Inflation Problem4
- Difficult to Advance3
- Difficult to Remove3
- Material Twisted/Bent3
- Deformation Due to Compressive Stress2
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- Insufficient Information9
NanoCross Elite models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NanoCross™ Elite AB14W050150150Catheter, angioplasty, peripheral, transluminal1 recall12 reports
- NanoCross™ Elite AB14W050020090Catheter, angioplasty, peripheral, transluminal1 recall3 reports
- NanoCross™ Elite AB14W050200150Catheter, angioplasty, peripheral, transluminal1 recall3 reports
- NanoCross™ Elite AB14W060200150Catheter, angioplasty, peripheral, transluminal1 recall3 reports
- NanoCross™ Elite AB14W060150150Catheter, angioplasty, peripheral, transluminal1 recall2 reports
- NanoCross™ Elite AB14W050040150Catheter, angioplasty, peripheral, transluminal1 recall1 report
- NanoCross™ Elite AB14W050060150Catheter, angioplasty, peripheral, transluminal1 recall1 report
- NanoCross™ Elite AB14W050120150Catheter, angioplasty, peripheral, transluminal1 recall1 report
- NanoCross™ Elite AB14W060080150Catheter, angioplasty, peripheral, transluminal1 recall1 report
- NanoCross™ Elite AB14W050020150Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- NanoCross™ Elite AB14W050040090Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- NanoCross™ Elite AB14W050080090Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- NanoCross™ Elite AB14W050080150Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- NanoCross™ Elite AB14W050200090Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- NanoCross™ Elite AB14W060040090Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- NanoCross™ Elite AB14W060040150Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- NanoCross™ Elite AB14W060060150Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- NanoCross™ Elite AB14W060100150Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- NanoCross™ Elite AB14W060120150Catheter, angioplasty, peripheral, transluminal1 recall0 reports
- NanoCross™ Elite AB14W025210150Catheter, angioplasty, peripheral, transluminal5 reports
- NanoCross™ Elite AB14W030210150Catheter, angioplasty, peripheral, transluminal4 reports
- NanoCross™ Elite AB14W030040150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W040080150Catheter, percutaneous2 reports
- NanoCross™ Elite AB14W040150150Catheter, percutaneous2 reports
- NanoCross™ Elite AB14W020210150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W025080090Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W025080150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W040040150Catheter, percutaneous1 report
- NanoCross™ Elite AB14W040120150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W040210150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W060020150Catheter, angioplasty, peripheral, transluminal1 report
Recent NanoCross Elite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Burst Container or Vessel
It was reported that during use of a Nanocross Elite PTA balloon catheter device, for the treatment of a calcified lesion in the proximal and mid section of the left superficial femoral artery, a pin-hole balloon burst (Balloon Burst AT, BELOW, or UNKNOWN Rated Burst Pressure) occurred on the second inflation. The vessel was post-dilated with a (Medtronic) 5 x 150 Nanocross. The balloon did not pass through a previously deployed stent. No resistance was encountered when advancing the device. The balloon was inflated with a (Merit Medical) inflation device using 50/50 contrast fluid. No damage was noted to the packaging and no issues were noted when removing the device from the hoop/tray. The IFU was followed without issue. It is not known at what pressure the balloon burst. The balloon did not detach during the procedure. The device was safely removed from the patient. The procedure was completed using a new (Medtronic) 5 x 150 Nanocross device. The patient was reported as alive, with no injury. No injury or intervention was associated with this event. No health consequences or impact were reported as a result of this event. No patient symptoms or complications have been reported a
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948212 ↗InjuryAug 12, 2026Burst Container or Vessel; Detachment of Device or Device Component
It was reported that during treatment of a distal tibial/popliteal trunk peripheral arterial plaque lesion with minimal tortuosity and moderate calcification, the NANOCROSS 014 percutaneous transluminal angioplasty balloon burst during the first inflation at 4 ATM and detached. The balloon was inflated using an inflation device with 50/50 contrast. All balloon fragments were retrieved from the vessel through an intervention, and the device was safely removed. The procedure was completed using a new device. No patient complications have been reported as a result of this event.
Patient problems: Insufficient Information
MAUDE report 50219398 ↗MalfunctionApr 26, 2026Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 AND NANOCROSS ELITE BALLOON CATHETERS TO TREAT A SEVERELY CALCIFIED TARGET LESION IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY, THE EVERCROSS 035 BALLOON BURST CIRCUMFERENTIALLY/RADIALLY ON THE FIRST INFLATION. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE WITH 50/50 CONTRAST, NO EMBOLIC PROTECTION WAS USED, THE VESSEL WAS PRE-DILATED, THE BALLOON DID NOT DETACH AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NEW BALLOON CATHETER WAS THEN USED. IT WAS FURTHER REPORTED THAT DURING CONTINUED TREATMENT WITH THE NANOCROSS ELITE BALLOON CATHETER, THE BALLOON BURST CIRCUMFERENTIALLY/RADIALLY ON THE FIRST INFLATION. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE WITH 50/50 CONTRAST, NO EMBOLIC PROTECTION WAS USED, THE VESSEL WAS POST-DILATED, THE BALLOON DID NOT DETACH AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED FOLLOWING THE NANOCROSS ELITE BALLOON BURST. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24993871 ↗MalfunctionMar 5, 2026Deflation Problem
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING THE NANOCROSS 014 BALLOON CATHETER IN THE LEFT SUPERFICIAL FEMORAL ARTERY (MID AND DISTAL SEGMENTS) OF A PATIENT WITH, SEVERE CALCIFICATION AND A CHRONIC TOTAL OCCLUSION IN A SHORT SEGMENT WITH 80-90% STENOSIS IN THE REMAINING SEGMENT WERE PRESENT. THE LESION MEASURED 120 MM IN LENGTH WITH A VESSEL DIAMETER OF 5 MM. MINIMAL RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE VESSEL WAS PRE-DILATED WITH A NANO 4/80 DEVICE. DEFLATION DIFFICULTIES WERE NOTED WITH THE BALLOON CATHETER; THE BALLOON WAS INFLATED TO 18 ATM AND THEN RAPIDLY DEFLATED TO 4 ATM, WITH NO CONTRAST OBSERVED IN THE INFLATOR. THE BALLOON REQUIRED MULTIPLE INFLATIONS AND DEFLATIONS WITH SALINE TO THIN THE CONTRAST MIX, AND THE BALLOON AND SHEATH WERE EVENTUALLY PULLED OUT OF THE BODY AFTER APPROXIMATELY 10 MINUTES. THE BALLOON WAS INFLATED WITH WHAT THEY BELIEVE TO BE A 70/30 CONTRAST TO SALINE MIX. BECAUSE THE CONTRAST AMOUNT WAS TOO MUCH IT IS BELIEVED THAT THIS CAUSED THE ISSUE WITH DEFLATION. THE DEVICE WAS SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORT ED AS A RESUL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519505 ↗MalfunctionMar 5, 2026Deflation Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE NANOCROSS 014 DEVICE TO TREAT PERIPHERAL ARTERY PLAQUE IN THE RIGHT MID POSTERIOR TIBIAL ARTERY (70% STENOSIS, 250 MM LESION LENGTH, 3 MM ARTERY DIAMETER, MODERATE CALCIFICATION, MINIMAL TORTUOSITY), THERE WERE DELAYS IN SURGERY OF FIVE MINUTES DUE TO PRODUCT MALFUNCTION. DEFLATION DIFFICULTIES WERE ENCOUNTERED, AS THE BALLOON COULD NOT BE FULLY DEFLATED FOR REMOVAL. THE BALLOON DETACHED WITHIN THE SHEATH, AND CATHETER TOLERANCE WAS DEGRADED. THE SHEATH USED WAS A 6FR DESTINATION, AND THE GUIDEWIRE WAS A .014 GLADIUS. THE VESSEL WAS POST-DILATED WITH A NANO 3-2.5 DEVICE, AND INFLATION WAS PERFORMED WITH A PROGRAMMER 26 USING A 70 SALINE/30 CON FLUID. NEGATIVE PRESSURE AND PULLING WERE APPLIED TO DEFLATE THE BALLOON. THE DETACHED BALLOON COMPONENT WAS REMOVED WITHIN THE SHEATH, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY REMOVING EVERYTHING WITH THE WIRE IN PLACE AND A NEW SHEATH TO FINISH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24517131 ↗MalfunctionFeb 25, 2026Difficult to Advance; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE USING THE NANOCROSS ELITE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON TO TREAT A SEVERELY CALCIFIED, SEVERELY TORTUOUS LESION IN THE DISTAL RIGHT PEDAL ARTERY, A BALLOON TWIST WAS OBSERVED. A REWRAP TOOL WAS NOT USED. A REWRAP ISSUE WAS NOT NOTED. A 7FR SHEATH AND A 0.014 GUIDEWIRE WERE USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, BUT NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT THERE WAS NO PROBLEM WITH FIRST INFLATION, BUT THE BALLOON COULD NOT FULLY INFLATE DURING SECOND INFLATION. A REPLACEMENT NON-MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24440067 ↗InjuryDec 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING TREATMENT OF A FIBROUS LESION IN THE RIGHT PROXIMAL/MID SUPERFICIAL FEMORAL ARTERY WITH A NANOCROSS ELITE PTA BALLOON, THERE WAS A ONE-HOUR DELAY IN SURGERY DUE TO A DETACHED BALLOON AT THE TARGET LESION. ARTERY DIAMETER REPORTED AS 6MM. A 6FR NON-MEDTRONIC SHEATH WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST FLUID FOR BALLOON INFLATION. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED 6MM PROTEGE EVERFLEX STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE VESSEL WAS POST-DILATED. THE DETACHED BALLOON WAS SNARED AND REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23755875 ↗InjuryNov 12, 2025Deflation Problem; Inflation Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deflation Problem; Inflation Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE NANOCROSS 014, DEFLATION DIFFICULTIES OCCURRED WHEN THE BALLOON WOULD NOT DEFLATE. A SMALL KINK IN THE CATHETER WAS NOTICED AFTER REMOVAL. THE PROCEDURE WAS ABORTED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERIES, SPECIFICALLY THE COMMON ILIAC ARTERY, SUPERFICIAL FEMORAL ARTERY, AND POPLITEAL ARTERY, WITH AN ARTERY DIAMETER OF 6MM AND CALCIFICATION PRESENT. THE VESSEL WAS PRE-DILATED AND THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE, AND DEFLATION WAS ATTEMPTED BY SNARING THROUGH A TRAILBLAZER. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY, AND INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23533172 ↗MalfunctionNov 3, 2025Deflation Problem; Difficult to Remove; Compatibility Problem; Material Deformation; Deflation Problem; Difficult to Remove; Compatibility Problem; Material Deformation
IT WAS REPORTED THAT DURING TREATMENT OF A SOFT TISSUE LESION IN THE MID LEFT POSTERIOR TIBIAL ARTERY USING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY NANOCROSS 014, THE BALLOON INFLATED AND TRACKED INTO THE BODY WITHOUT ISSUE, BUT DEFLATION DIFFICULTIES OCCURRED AS THE BALLOON WOULD NOT FULLY DEFLATE FOR APPROXIMATELY TWO MINUTES. THE BALLOON CATHETER APPEARED TO STRETCH DURING REMOVAL AND BECAME STUCK ON THE WIRE, REQUIRING BOTH THE BALLOON CATHETER AND WIRE TO BE REMOVED TOGETHER. AFTER REMOVAL FROM THE BODY, THE WIRE COULD NOT BE SEPARATED FROM THE CATHETER, AS IT WAS STUCK INSIDE, AND THE BALLOON CATHETER APPEARED STRETCHED AND DETACHED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE OF THE SAME MAKE AND MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23450685 ↗MalfunctionSep 15, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT PLAQUE IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY USING A NANOCROSS ELITE BALLOON, THE BALLOON BURST AT 10 ATM PRESSURE ON THE FIRST INFLATION. THE LESION LENGTH WAS 30MM AND THE ARTERY DIAMETER WAS 6MM. THE VESSEL WAS PRE-DILATED AND POST-DILATED, AND THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED PROTEGE STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE BALLOON DID NOT DETACH DURING THE EVENT, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER NANOCROSS DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23050965 ↗MalfunctionSep 10, 2025Deflation Problem; Deflation Problem
A DEVICE WAS RETURNED TO CUSTOMER SERVICES AND ON INSPECTION OF THE DEVICE IT WAS NOTED THAT CRIMP MARKS WERE FOUND ON THE BALLOON BOND. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23015332 ↗MalfunctionSep 2, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE NANOCROSS 014 BALLOON, A CHRONIC TOTAL OCCLUSION (100% STENOSIS) OF THE DISTAL TIBIAL/POPLIETAL TRUNK WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION WAS PRESENT. DURING BALLOON INFLATION, THE BALLOON BURST AND A CATHETER LEAK OCCURRED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE. NO EMBOLIC PROTECTION WAS USED, AND NO RESISTANCE OR EXCESSIVE FORCE WAS ENCOUNTERED DURING DEVICE ADVANCEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22931727 ↗MalfunctionAug 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER DEVICE FOR PATIENT TREATMENT IN THE PERONEAL ARTERY. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS REPORTED THAT THERE WAS A BALLOON TWIST NOTED DURING THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738056 ↗MalfunctionAug 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER DEVICE FOR PATIENT TREATMENT. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS REPORTED THAT THERE WAS A BALLOON TWIST NOTED DURING THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22714257 ↗MalfunctionJun 27, 2025Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem
IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY USING THE NANOCROSS ELITE 5MM X 200MM X 150CM BALLOON, THERE WERE DEFLATION DIFFICULTIES AND THE BALLOON WAS TAKEN TO 16 ATM WITH MINIMAL INFLATION. THE SHEATH USED WAS A 6FR X 45 NON-MEDTRONIC SHEATH AND THE GUIDEWIRE WAS A .014 NON-MEDTRONIC GUIDEWIRE. THE BALLOON WAS INFLATED WITH A 50/50 CONTRAST SOLUTION USING A NON-MEDTRONIC INFLATION DEVICE. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOVAL USING NEGATIVE PRESSURE FROM THE INFLATION DEVICE, WHICH TOOK 2 MINUTES. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE OF THE SAME MAKE AND MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22344090 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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