NA 530.715Recalls & reported problems
Synthes GmbH · BATTERY RECIPROCATOR II · Class 1
Quick summary
This Synthes Battery Reciprocator II surgical motor has 394 reports in the FDA database, with no deaths and no injuries. Many reports describe the device sticking or moving stiffly, losing power completely or intermittently, and leaking liquid. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 390
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 390 adverse event reports that list this exact device (DI 10886982240149), received between Dec 4, 2017 and Jul 1, 2026 — classified as 390 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (130 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking130
- Complete Loss of Power88
- Leak/Splash71
- Intermittent Loss of Power50
- Excessive Heating34
- Appropriate Device Problem Term/Code Not Available28
- Noise, Audible28
- Mechanical Jam25
Patient problems
- No Clinical Signs, Symptoms or Conditions267
- No Consequences Or Impact To Patient97
- No Known Impact Or Consequence To Patient26
Recent adverse event reports
The 25 most recent of 390 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2026Mechanical Jam
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY RECIPROCATOR FOR BPL DEVICE TRIGGER MOVING PARTS DID NOT MOVE SMOOTHLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25682636 ↗MalfunctionJun 17, 2026Mechanical Jam; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY RECIPROCATOR II FOR BPL II DEVICE [TRIGGER MOVING PARTS DID NOT MOVE SMOOTHLY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537227 ↗MalfunctionJun 17, 2026Mechanical Jam; Noise, Audible; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY RECIPROCATOR II FOR BPL II DEVICE TRIGGER MOVING PARTS DID NOT MOVE SMOOTHLY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE MADE A SOUND AND DID NOT WORK. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534363 ↗MalfunctionMay 28, 2026Leak/Splash; Output below Specifications
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE HAD A LIQUID LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD LOW POWER. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323134 ↗MalfunctionMay 28, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY RECIPROCATOR DEVICE HAD A STICKY TRIGGER, THE ELECTRICAL CONTROL UNIT WAS DAMAGED ¿ WILL NOT RUN, HAD A BROKEN GEAR, WORN MOTOR, AND A WORN COUPLING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK QUICK COUPLING FOR SAW BLADES, CHECK FOR STICKY TRIGGER, CHECK FUNCTION OF DEVICE, AND CHECK RECIPROCATING FREQUENCY WITH FREQUENCY METER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322548 ↗MalfunctionMay 13, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY RECIPROCATOR DEVICE HAD A STICKY TRIGGER, THE ELECTRICAL CONTROL UNIT WAS DAMAGED ¿ WILL NOT RUN, AND THE MOTOR WAS DAMAGED ¿ WILL NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR STICKY TRIGGER, CHECK THE FUNCTION OF THE DEVICE, AND CHECK RECIPROCATING FREQUENCY WITH FREQUENCY METER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163166 ↗MalfunctionApr 30, 2026Break; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOVING PARTS OF THE TRIGGER DID NOT MOVE SMOOTHLY ON THE BATTERY RECIPROCATOR DEVICE. IT WAS NOTED IN THE SERVICE ORDER THAT THE TIP OF THE DEVICE WAS DAMAGED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048938 ↗MalfunctionApr 27, 2026Complete Loss of Power; Intermittent Loss of Power; Excessive Heating
IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION THE BATTERY RECIPROCATOR DEVICE EXPERIENCED HEAT AND INTERMITTENT OPERATION. IT WAS NOTED BY THE REPORTER THAT DURING PRE-SURGERY THE DEVICE DID NOT TURN ON. MULTIPLE BATTERIES WERE TRIED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001815 ↗MalfunctionApr 23, 2026Intermittent Loss of Power
IT WAS REPORTED THAT THE BATTERY HANDPIECE DEVICE RAN INTERMITTENTLY. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966759 ↗MalfunctionApr 13, 2026Leak/Splash
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY RECIPROCATOR DEVICE FAILED FUNCTIONAL TEST FOR LEAK - LIQUID. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24863879 ↗MalfunctionApr 9, 2026Noise, Audible; Physical Resistance/Sticking; Intermittent Loss of Power
IT WAS REPORTED THAT THE OPERATION SOMETIMES STOPPED ON THE BATTERY RECIPROCATOR DEVICE. THE TRIGGER INTERMITTENTLY CAUGHT AND THERE WAS A SLIGHT SOUND BLUR. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829227 ↗MalfunctionMar 25, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE HAD MOVING PARTS DO NOT MOVE SMOOTHLY - TRIGGER. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24686061 ↗MalfunctionFeb 20, 2026Device Reprocessing Problem; Leak/Splash
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY RECIPROCATOR DEVICE WAS LEAKING A LIQUID. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD DIRT. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400235 ↗MalfunctionFeb 19, 2026Complete Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE HAD INTERMITTENT OPERATION. IT WAS NOTED IN THE SERVICE ORDER THAT DURING A TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS, THE DEVICE WOULD NOT START. SINCE THE DEVICE HAD ALREADY BEEN USED, THE OPERATION WAS NOT AFFECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24391179 ↗MalfunctionFeb 19, 2026Leak/Splash; Output below Specifications
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY RECIPROCATOR DEVICE WAS LEAKING LIQUID, HAD LOW POWER, AND CONTACT DAMAGE. IT WAS NOTED THAT THE DEVICE HAD INSUFFICIENT OUTPUT, DIRTY TERMINALS, AND FLUID COMING OUT OF THE SLEEVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK POSITIONING OF SAW HEAD, AND CHECK RECIPROCATING FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD LOW POWER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388756 ↗MalfunctionFeb 18, 2026Intermittent Loss of Power
IT WAS REPORTED THAT THE BATTERY RECIPROCATOR DEVICE WOULD STOP BY ITSELF. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378722 ↗MalfunctionFeb 18, 2026Intermittent Loss of Power; Excessive Heating
IT WAS REPORTED THAT DURING AN ARTHROPLASTY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BATTERY RECIPROCATOR DEVICE SAW WAS TRIGGERED AT THE START OF THE CASE AND IT FUNCTIONED. HOWEVER, WHEN THE SAW WAS TRIGGERED AGAIN INTRA-OP THE SAW DID NOT WORK. THE BATTERY WAS CHANGED TO RULE OUT A BATTERY PROBLEM. THE SAW WAS TRIGGERED MULTIPLE TIMES AND THE HANDPIECE GREW HOT TO TOUCH EVENTUALLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377320 ↗MalfunctionDec 30, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE BATTERY RECIPROCATOR DEVICE WAS LEAKING A LIQUID. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23925554 ↗MalfunctionDec 26, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE BATTERY RECIPROCATOR DEVICE WAS LEAKING A LIQUID. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23897006 ↗MalfunctionDec 26, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE BATTERY RECIPROCATOR DEVICE HAD A LIQUID LEAK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895588 ↗MalfunctionNov 17, 2025Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THE BATTERY RECIPROCATOR EXHIBITED UNSTABLE OPERATION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23572131 ↗MalfunctionNov 17, 2025Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THE BATTERY RECIPROCATOR DEVICE HAD UNSTABLE OPERATION AND STOPPED EACH TIME THAT IT STARTED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23570789 ↗MalfunctionNov 14, 2025Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THE BATTERY RECIPROCATOR II FOR BPL II DEVICE SOMETIMES STOPPED BY ITSELF. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556162 ↗MalfunctionNov 14, 2025Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT THE LOCK AND TRIGGER ON THE BATTERY RECIPROCATOR II FOR BPL II DID NOT MOVE SMOOTHLY. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS UNKNOWN IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23554865 ↗MalfunctionNov 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY RECIPROCATOR DEVICE HAD A STICKY TRIGGER, COULD NOT DISENGAGE ATTACHMENT-COUPLING AND HAD WORN GEAR. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK QUICK COUPLING FOR SAW BLADES AND CHECK FOR STICKY TRIGGER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23462204 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.