KYPHON Express II Inflatable Bone Tamp KE152 (UDI 00763000312039)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000312039), received between Sep 27, 2021 and Dec 1, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (21 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY DUE TO T10 COMPRESSION FRACTURE (PRIMARY OSTEOPOROSIS). IT WAS REPORTED THAT THE IBTRUPTURED DURING EXPANSION (APPROXIMATELY 1.5 CC AT 300 PSI); THERE WAS NO RETAINED BALLOON FRAGMENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER CLEANING AND CEMENT FILL WITH FINAL INSTRUMENTATION, WITHOUT DELAY OR HOSPITALIZATION. THE PATIENT EXPERIENCED NO SYMPTOMS OR COMPLICATIONS AND RECOVERED WITH NO HEALTH DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677982 ↗
• MalfunctionOct 30, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING F ILLING CEMENT AS PART OF L2 BKP PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT IBT ONLY BULGED FROM THE INSERTION SITE TO THE HEAD. THE BALLOON RUPTURED AROUND THE UPPER END PLATE. AFTER THE BALLOON RUPTURE, THE IBT COULD NOT BE PULLED OUT FROM THE CANNULA OF THE OSTEO INTRODUCER, SO THE IBT STYLET WAS PULLED OUT AND THEN PULLED OUT, BUT HALF OF THE TIP OF THE BALLOON AND THE X-RAY MARKER WERE SEPARATED AND REMAINED IN THE BODY. THERE WAS A DELAY OF LESS THAN 60 MINS. THERE IS NO PLAN FOR AN ADDITIONAL PROCEDURE TO REMOVE THE BALLOON TIP WHICH IS IN PATIENT'S BODY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23424961 ↗
• MalfunctionSep 5, 2025Material Rupture; Material Rupture

  (B)(4) (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L1 TRANSCUTANEOUS VERTEBROPLASTY PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. PATIENT MEDICAL HISTORY: HYPERTENSION, HYPERLIPIDEMIA, APPENDICITIS, CATARACT, CEREBRAL INFARCTION, BRONCHIAL ASTHMA. IT WAS REPORTED THAT WHEN THE BALLOON WAS INSERTED AND INFLATED, IT RUPTURED AT 310PSI. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976503 ↗
• MalfunctionSep 5, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L3 BKP PROCEDURE IN A PATIENT DIAGNOSED WITH VERTEBRAL FRACTURE DUE TO OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON RUPTURED WHEN THE L3 BALLOON WAS INFLATED AT 200PSI AT 2CC. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976308 ↗
• MalfunctionJul 14, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A BKP PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT BREAKAGE WAS CONFIRMED DURING BALLOON INFLATION ON ONE SIDE, SO IT WAS REMOVED ONCE. BREAKAGE WAS CONFIRMED AGAIN WHEN THE USED BALLOON WAS USED ON THE CONTRALATERAL SIDE. WHEN THE BALLOON WAS INFLATED, IT WAS CONFIRMED THAT CONTRAST MEDIUM WAS LEAKING FROM THE BALLOON AT AROUND 200PSI, AND AFTER IT WAS REMOVED, A PINHOLE-SIZED HOLE WAS FOUND. THERE WAS A DELAY OF LESS THAN 60 MINS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492465 ↗
• MalfunctionJun 12, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A BONE TAMP KIT HAVING BALLOON KYPHOPLASTY (BKP) THERAPY. IT WAS REPORTED THAT BALLOON GOT DAMAGED AND RUPTURED DURING BKP SURGERY ON EXPANDING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192572 ↗
• MalfunctionJun 12, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE BALLOON RUPTURED WHEN THE PHYSICIAN WAS PULLING THE DEFLATED BALLOON OUT OF THE CANNULA. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191803 ↗
• MalfunctionJun 9, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A BKP PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE. THE RUPTURE OCCURRED DURING BALLOON EXPANSION. IT WAS REPORTED THAT DURING EXPANSION IBT RUPTURED. THE INCIDENT INVOLVED BALLOON DAMAGE (ON ONE SIDE) DURING EXPANSION. AFTER THE DAMAGE, THE BALLOON FROM THE OPPOSITE SIDE WAS INSERTED INTO THE DAMAGED SIDE AND EXPANDED AGAIN. THE OPERATION WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165360 ↗
• MalfunctionMay 27, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPLASTY FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING EXPANSION THE BALLOON WAS RUPTURED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT PRODUCT WAS USED ACCORDING TO IFU AND NOT DELIVERED AS DEFECTIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22086762 ↗
• MalfunctionMay 21, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5 BALLOON KYPHOPLASTY DUE TO PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). IT WAS REPORTED THAT BALLOON RUPTURED DURING BALLOON INFLATION(L5 RIGHT) . THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058722 ↗
• MalfunctionMay 16, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSCUTANEOUS VERTEBROPLASTY THERAPY FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING THE BKP PROCEDURE, A BALLOON BURST INSIDE THE VERTEBRAL BODY WHILE BEING INFLATED, RESULTING IN A TEAR. A NEW BALLOON WAS OPENED, AND IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032750 ↗
• MalfunctionMay 13, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY FOR L1 COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON BROKE, RESULTING IN THE CONTRAST AGENT FLOWING OUT INTO THE VERTEBRAL BODY. THE IBT WAS WITHDRAWN AND THE CONTRAST MEDIUM INSIDE THE VERTEBRAL BODY WAS COLLECTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007651 ↗
• MalfunctionMay 12, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSCUTANEOUS VERTEBROPLASTY (L1) DUE TO COMPRESSION FRACTURE (PRIMARY OSTEOPOROSIS). IT WAS REPORTED THAT  THE BALLOON WAS INFLATED DURING THE INITIAL INSERTION AND THEN CAREFULLY EXPANDED ONCE THE PRESSURE HAD DECREASED, BUT THE BALLOON BROKE/RUPTURED. PRE RUPTURE PRESSUE WAS 350 PSI. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004005 ↗
• MalfunctionMay 12, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY. PRE-OP DIAGNOSIS OF PATIENT WAS COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT, THE BALLOON WAS RUPTURED DURING EXPANSION. THERE WERE NO FRAGMENTS OF RUPTURED BALLOON LEFT INSIDE THE PATIENT. NO TIME DELAY IN PROCEDURE REPORTED. THE LEVELS TREATED WERE UNKNOWN. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000209 ↗
• MalfunctionMay 9, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOP LASTY FOR BONE METASTASIS. IT WAS REPORTED THAT BALLOONS WERE INFLATED AT L5 LEVEL AFTER OSTEOCOOL ABLATION. BOTH BALLOONS POPPED. THE BALLOON ON THE PATIENTS RIGHT SIDE RUPTURED IN THE VERTEBRAL BODY AND A PORTION OF BALLOON WITH DISTAL RADIOPAQUE MARKER REMAINED WITHIN THE VERTEBRAL BODY. PHYSICIAN COMPETED THE PROCEDURE WITH CEMENT AUGMENTATION AT THIS LEVEL. THE BALLOON RUPTURED/POPPED AND THE RADIOPAQUE MARKER FROM THE BALLOON WAS LEFT INSIDE OF THE VERTEBRAL BODY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21994580 ↗
• MalfunctionMay 9, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOP LASTY FOR BONE METASTASIS. IT WAS REPORTED THAT BALLOONS WERE INFLATED AT L5 LEVEL AFTER OSTEOCOOL ABLATION. BOTH BALLOONS POPPED. THE BALLOON ON THE PATIENTS RIGHT SIDE RUPTURED IN THE VERTEBRAL BODY AND A PORTION OF BALLOON WITH DISTAL RADIOPAQUE MARKER REMAINED WITHIN THE VERTEBRAL BODY. PHYSICIAN COMPETED THE PROCEDURE WITH CEMENT AUGMENTATION AT THIS LEVEL. THE BALLOON RUPTURED/POPPED AND THE RADIOPAQUE MARKER FROM THE BALLOON WAS LEFT INSIDE OF THE VERTEBRAL BODY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21994540 ↗
• MalfunctionMay 5, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS VERTEBROPLASTY DUE TO PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE) IT WAS REPORTED THAT IBT RUPTURED DURING EXPANSION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961631 ↗
• MalfunctionApr 30, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS VE RTEBRAL ANGIOPLASTY. PRE-OP DIAGNOSIS OF THE PATIENT WAS COMPRESSION FRACTURE AND INTRASPINAL CLEFT DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT, THE BALLOON WAS RUPTURED. WHILE THE BALLOON WAS INFLATING IN THE L2 VERTEBRAL BODY, ONLY ONE SIDE OF THE BALLOON WAS DAMAGED. THE PRESSURE INDICATED 250PSI. THE LEVELS PLANNED TO TREAT WERE SECOND LUMBAR VERTEBRA. NO FRAGMENTS OF RUPTURED BALLOON WAS LEFT INSIDE PATIENT. SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936397 ↗
• MalfunctionJun 19, 2024Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T9 AND T12 KYPH OPLASTY FOR VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING INFLATION OF THE BALLOON, IT BURST. THE SURGEON WAS ABLE TO PULL OUT ALL BUT THE DISTAL END OF THE BALLOON WHEN HE REMOVED THE BALLOON FROM THE BODY. THE BALLOON WAS USED ON T12 AND THEN REUSED ON T9. THE BALLOON WAS NOT OVER INFLATED AND IT HAD NOT REACHED ITS MAXIMUM PSI . THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564442 ↗
• MalfunctionNov 14, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR VERTEBRAL COMPRESSION FRACTURES AT T11 AND L3. IT WAS REPORTED THAT WHILE INFLATING THE BALLOON, IT POPPED UNDER 300PSI. PRODUCT WAS DISCARDED. PROCEDURE COMPLETED WITH A NEW PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS A BALLOON KYPHOPLASTY. THE PROCEDURE WAS DELAYED 10 MINUTES AS NEW PRODUCT HAD TO BE OPENED AND PREPPED PRIOR TO USE. THE PRODUCT WAS INSIDE THE PATIENT WHEN THE BALLOON RUPTURED. THERE WERE NO ADVERSE EVENTS TO THE PATIENT BECAUSE OF THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129595 ↗
• MalfunctionMar 31, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT, BALLOON BROKE OFF AFTER GETTING STUCK IN THE VERTEBRAL BODY AND CEMENT SURROUNDED THE BALLOON. UPON REMOVAL, BALLOON WAS STUCK AND THE INNER STYLET WAS REMOVED. BALLOON BECAME STUCK IN THE VERTEBRAL BODY AND RADIOPAQUE MARKERS AND BALLOON WERE LEFT IN VERTEBRAL BODY. THE LEVELS TREATED WERE L5. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ORIGINAL PRODUCT. THERE WAS NO PLAN TO RETRIEVE THE BROKEN BALLOON LEFT INSIDE THE VERTEBRAL BODY. THERE WERE NO SYMPTOMS TO PATIENT REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13963752 ↗
• MalfunctionSep 27, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING IBTS IN A KYPHOPLASTY FOR A VERTEBRAE FRACTURE AT T10 AND T12. IT WAS REPORTED THAT THE HCP TRIED TO CURVE THE IBTS BY BENDING THE INNER GUIDEWIRE. WHEN FORCING THE IBTS DOWN THE PATH CREATED IN THE BONE, THE GUIDEWIRE PUSHED FORWARD AND PUNCTURED THE IBTS. THE RUPTURES OCCURRED DURING INFLATION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THERE WAS A DELAY IN OVERALL PROCEDURE TIME BY APPROX. 3 MINUTES. THERE WAS NO IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY OR TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531243 ↗