Jade PTA Balloon Dilatation CatheterRecalls & reported problems across all models
OrbusNeich Medical (ShenZhen) Co., Ltd. · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls
- 0
We found 15 models of Jade PTA Balloon Dilatation Catheter by OrbusNeich Medical (ShenZhen) Co., Ltd. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Apr 25, 2024 and Jul 8, 2026 — classified as 31 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (20 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. 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
Most reported Jade PTA Balloon Dilatation Catheter problems
Device problems
- Material Separation20
- Material Split, Cut or Torn10
- Material Rupture9
- Entrapment of Device2
Patient problems
- Foreign Body In Patient25
- No Clinical Signs, Symptoms or Conditions11
Jade PTA Balloon Dilatation Catheter models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Jade PTA Balloon Dilatation Catheter 596015022Catheter, Angioplasty, Peripheral, Transluminal5 reports
- Jade PTA Balloon Dilatation Catheter 586010022Catheter, Angioplasty, Peripheral, Transluminal3 reports
- Jade PTA Balloon Dilatation Catheter 586024022Catheter, Angioplasty, Peripheral, Transluminal3 reports
- Jade PTA Balloon Dilatation Catheter 596024022Catheter, Angioplasty, Peripheral, Transluminal3 reports
- Jade PTA Balloon Dilatation Catheter 597010022Catheter, Angioplasty, Peripheral, Transluminal3 reports
- Jade PTA Balloon Dilatation Catheter 581524022Catheter, Angioplasty, Peripheral, Transluminal2 reports
- Jade PTA Balloon Dilatation Catheter 585015022Catheter, Angioplasty, Peripheral, Transluminal2 reports
- Jade PTA Balloon Dilatation Catheter 586008022Catheter, Angioplasty, Peripheral, Transluminal2 reports
- Jade PTA Balloon Dilatation Catheter 582524032Catheter, Angioplasty, Peripheral, Transluminal2 reports
- Jade PTA Balloon Dilatation Catheter 596008022Catheter, Angioplasty, Peripheral, Transluminal2 reports
- Jade PTA Balloon Dilatation Catheter 597004022Catheter, Angioplasty, Peripheral, Transluminal2 reports
- Jade PTA Balloon Dilatation Catheter 596024032Catheter, Angioplasty, Peripheral, Transluminal2 reports
- Jade PTA Balloon Dilatation Catheter 585024022Catheter, Angioplasty, Peripheral, Transluminal1 report
- Jade PTA Balloon Dilatation Catheter 595015022Catheter, Angioplasty, Peripheral, Transluminal1 report
- Jade PTA Balloon Dilatation Catheter 604015022Catheter, Angioplasty, Peripheral, Transluminal1 report
Recent Jade PTA Balloon Dilatation Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Material Separation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESION IN AN UNSPECIFIED RIGHT LOWER EXTREMITY ARTERY. DURING THE PROCEDURE VIA COMMON FEMORAL ARTERY ACCESS THE TIP OF THE 6.0MM X 80MM JADE 14 PTA OTW BALLOON FRACTURED. SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE BALLOON TIP. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 7/7/2026: IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, MILD TORTUOUS, 90% STENOSED LESION IN RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) VIA COMMON FEMORAL ARTERY ACCESS. DURING THE PROCEDURE THE TIP OF THE 6.0MM X 80MM JADE 14 PTA OTW BALLOON FRACTURED UPON REMOVAL OF THE BALLOON FROM THE SHEATH AND CAME OFF INSIDE THE DISTAL SFA STENT. SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE BALLOON TIP BUT WAS NOT COMPLETELY SUCCESSFUL. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND DISCHARGED AS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED. Q1. ANATOMICAL INFORMATION? (VESSEL / LOCATION / TORTUOSITY / CALCIFICATION / STENOSIS % / ETC.) PLEASE PROVIDE REASON IF UNAVAILABLE (HOSPITAL POLICY, ETC.) A1. RIGHT SFA, DISTAL RIGHT SFA HEAVILY CALCIFIED, MILD TORTUOSITY AND 90% STENOSIS. Q2. IS THERE ANY INDICATION AS T
Patient problems: Foreign Body In Patient
MAUDE report 25757583 ↗InjuryJul 8, 2026Material Separation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESION IN AN UNSPECIFIED RIGHT LOWER EXTREMITY ARTERY. DURING THE PROCEDURE VIA COMMON FEMORAL ARTERY ACCESS THE TIP OF THE 6.0MM X 80MM JADE 14 PTA OTW BALLOON FRACTURED. SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE BALLOON TIP. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026: "IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, MILD TORTUOUS, 90% STENOSED LESION IN RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) VIA COMMON FEMORAL ARTERY ACCESS. DURING THE PROCEDURE THE TIP OF THE 6.0MM X 80MM JADE 14 PTA OTW BALLOON FRACTURED UPON REMOVAL OF THE BALLOON FROM THE SHEATH AND CAME OFF INSIDE THE DISTAL SFA STENT. SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE BALLOON TIP BUT WAS NOT COMPLETELY SUCCESSFUL. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND DISCHARGED AS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED. Q1. ANATOMICAL INFORMATION? (VESSEL / LOCATION / TORTUOSITY / CALCIFICATION / STENOSIS % / ETC.) PLEASE PROVIDE REASON IF UNAVAILABLE (HOSPITAL POLICY, ETC.) A1. RIGHT SFA, DISTAL RIGHT SFA HEAVILY CALCIFIED, MILD TORTUOSITY AND 90% STENOSIS Q2. IS THERE ANY INDICATION A
Patient problems: Foreign Body In Patient
MAUDE report 25757580 ↗InjuryMar 11, 2026Material Separation
IT WAS REPORTED THAT DURING PROCEDURE, A JADE BALLOON RUPTURED AND GOT TRAPPED IN-VIVO RESULTING IN SURGICAL CUTDOWN FOR REMOVAL OF THE BALLOON. ADDITIONAL INFORMATION WAS RECEIVED ON 2026/02/13: 1. DID THE BALLOON BECOME FULLY DETACHED OR WAS IT DAMAGED INTACT? - PART OF THE BALLOON BECAME DETACHED AS WELL AS THE BALLOON MARKER. THE OTHER HALF OF THE BALLOON WAS REMOVED FROM THE BODY. 2. WAS THERE ANY BALLOON FRAGMENTS LEFT IN-VIVO OR WAS IT COMPLETELY REMOVED? - IT WAS COMPLETELY REMOVED WITH SURGERY. 3. ANATOMICAL INFORMATION? (VESSEL / LOCATION / TORTUOSITY / CALCIFICATION / STENOSIS % / ETC.) - PROXIMAL SFA, HEAVY CALCIFICATION, ~90-95% STENOSIS. 4. WAS THERE A DELAY IN THE PROCEDURE THAT RESULTED IN PATIENT HARM? IF YES, WHAT WAS THE HARM? - NO. 5. WILL THE FACILITY RELEASE ANY IMAGES OR FILMS OF THE INCIDENT FOR REVIEW BY THE ENGINEERS? - NO. 6. WHAT IS THE STATUS OF THE PATIENT? - STABLE UPON COMPLETION OF THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 24573476 ↗InjuryMar 10, 2026Material Separation
IT WAS REPORTED THAT DURING PROCEDURE, A JADE BALLOON RUPTURED AND GOT TRAPPED IN-VIVO RESULTING IN SURGICAL CUTDOWN FOR REMOVAL OF THE BALLOON. ADDITIONAL INFORMATION WAS RECEIVED ON 2026/2/13: 1. DID THE BALLOON BECOME FULLY DETACHED OR WAS IT DAMAGED INTACT? PART OF THE BALLOON BECAME DETACHED AS WELL AS THE BALLOON MARKER. THE OTHER HALF OF THE BALLOON WAS REMOVED FROM THE BODY 2. WAS THERE ANY BALLOON FRAGMENTS LEFT IN-VIVO OR WAS IT COMPLETELY REMOVED? IT WAS COMPLETELY REMOVED WITH SURGERY. 3. ANATOMICAL INFORMATION? (VESSEL / LOCATION / TORTUOSITY / CALCIFICATION / STENOSIS % / ETC.) PROXIMAL SFA, HEAVY CALCIFICATION, 90-95% STENOSIS. 4. WAS THERE A DELAY IN THE PROCEDURE THAT RESULTED IN PATIENT HARM? IF YES, WHAT WAS THE HARM? NO 5. WILL THE FACILITY RELEASE ANY IMAGES OR FILMS OF THE INCIDENT FOR REVIEW BY THE ENGINEERS? NO 6. WHAT IS THE STATUS OF THE PATIENT? STABLE UPON COMPLETION OF THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 24565781 ↗InjuryNov 24, 2025Material Separation; Material Separation
IT WAS REPORTED THAT FOLLOWING LASER ATHERECTOMY, THE JADE BALLOON WAS USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) IN AN 80MM SEGMENT. THE BALLOON ADVANCED AND INFLATED WITH NO ISSUES, HOWEVER, THE ARTERY COULD NOT OPEN UP UPON INFLATION. SEVERAL ATTEMPTS WERE MADE AND THE SEGMENT DECREASED FROM 80MM TO 40MM, HOWEVER, COULD NOT OPEN FURTHER. DURING TREATMENT, THE BALLOON RUPTURED. WHEN THE BALLOON WAS AT THE 6F SHEATH, THE BALLOON ACCORDIONED AND UPON THE CATHETER REMOVAL, THE BALLOON MEMBRANE REMAINED IN VIVO AT THE EXTERNAL ILIAC/FEMORAL LOCATION. THE PATIENT WAS TRANSFERRED TO A HOSPITAL TO PERFORM SURGERY TO REMOVE THE FRAGMENT. THE COMPONENT WAS SUCCESSFULLY REMOVED. THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23640814 ↗InjuryNov 24, 2025Material Separation; Material Separation
IT WAS REPORTED THAT FOLLOWING LASER ATHERECTOMY, THE JADE BALLOON WAS USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) IN AN 80MM SEGMENT. THE BALLOON ADVANCED AND INFLATED WITH NO ISSUES, HOWEVER, THE ARTERY COULD NOT OPEN UP UPON INFLATION. SEVERAL ATTEMPTS WERE MADE AND THE SEGMENT DECREASED FROM 80MM TO 40MM, HOWEVER, COULD NOT OPEN FURTHER. DURING TREATMENT, THE BALLOON RUPTURED. WHEN THE BALLOON WAS AT THE 6F SHEATH, THE BALLOON ACCORDIONED AND UPON THE CATHETER REMOVAL, THE BALLOON MEMBRANE REMAINED IN VIVO AT THE EXTERNAL ILIAC/FEMORAL LOCATION. THE PATIENT WAS TRANSFERRED TO A HOSPITAL TO PERFORM SURGERY TO REMOVE THE FRAGMENT. THE COMPONENT WAS SUCCESSFULLY REMOVED. THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23640487 ↗InjurySep 4, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING PROCEDURE; THE JADE BALLOON WAS INFLATED IN MID SUPERFICIAL FEMORAL ARTERY (SFA) TO 8ATM AND IT RUPTURED. THE PHYSICIAN ATTEMPTED TO PULL THE BALLOON OUT OF THE SFA OVER THE WIRE AND IT COULD NOT MOVE, IT JUST ACCORDIONED. THE PEDAL ACCESS WAS OBTAINED IN AN ATTEMPT TO CAPTURE BALLOON WITH A SNARE. SOME OF THE BALLOON WAS SNARED OUT AND A STENT WAS PLACED TO ADHERE THE LEFTOVER BALLOON TO THE ARTERY WALL.
Patient problems: Foreign Body In Patient
MAUDE report 22968736 ↗InjurySep 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING PROCEDURE; THE JADE BALLOON WAS INFLATED IN MID SUPERFICIAL FEMORAL ARTERY (SFA) TO 8 ATM AND IT RUPTURED. THE PHYSICIAN ATTEMPTED TO PULL THE BALLOON OUT OF THE SFA OVER THE WIRE AND IT COULD NOT MOVE, IT JUST ACCORDION. THE PEDAL ACCESS WAS OBTAINED IN AN ATTEMPT TO CAPTURE BALLOON WITH A SNARE. SOME OF THE BALLOON WAS SNARED OUT AND A STENT WAS PLACED TO ADHERE THE LEFTOVER BALLOON TO THE ARTERY WALL.
Patient problems: Foreign Body In Patient
MAUDE report 22948898 ↗InjurySep 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING PROCEDURE; THE JADE BALLOON WAS INFLATED IN MID SUPERFICIAL FEMORAL ARTERY (SFA) TO 8 ATM AND IT RUPTURED. THE PHYSICIAN ATTEMPTED TO PULL THE BALLOON OUT OF THE SFA OVER THE WIRE AND IT COULD NOT MOVE, IT JUST ACCORDION. THE PEDAL ACCESS WAS OBTAINED IN AN ATTEMPT TO CAPTURE BALLOON WITH A SNARE. SOME OF THE BALLOON WAS SNARED OUT AND A STENT WAS PLACED TO ADHERE THE LEFTOVER BALLOON TO THE ARTERY WALL.
Patient problems: Foreign Body In Patient
MAUDE report 22948897 ↗MalfunctionAug 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE JADE BALLOON WAS USED WITH A NON-ABBOTT SHEATH VIA PEDAL ACCESS TO TREAT A LESION IN LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE BALLOON WAS INFLATED TO 18 ATMOSPHERES (ATM) FOR 2 MINUTES AND THEN DEFLATED. AN INDEFLATOR REMAINED HOOKED TO BALLOON AT NEGATIVE PRESSURE WHILE THE BALLOON WAS REMOVED FROM THE WIRE. THERE WAS RESISTANCE AND THE BALLOON SHEARED OFF AT MIDDLE POINT OF BALLOON, LEAVING HALF OF THE BALLOON ABOUT 50 MILLIMETERS (MM) IN-VIVO AS IT WAS TAKEN OUT OF THE BODY. NEW BALLOONS ACROSS FRAGMENTED BALLOON WERE PLACED TO SNARE THE FRAGMENT AND A SNARE WAS USED TO ATTEMPT FOR REMOVAL OF THE FRAGMENT. A STENT WAS PLACED TO ADHERE BALLOON AGAINST THE ARTERY WALL. THE PATIENT'S STATUS WAS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 22813616 ↗InjuryAug 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE JADE BALLOON WAS USED WITH A NON-ABBOTT SHEATH VIA PEDAL ACCESS TO TREAT A LESION IN LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE BALLOON WAS INFLATED TO 18 ATMOSPHERES (ATM) FOR 2 MINUTES AND THEN DEFLATED. AN INDEFLATOR REMAINED HOOKED TO BALLOON AT NEGATIVE PRESSURE WHILE THE BALLOON WAS REMOVED FROM THE WIRE. THERE WAS RESISTANCE AND THE BALLOON SHEARED OFF AT MIDDLE POINT OF BALLOON, LEAVING HALF OF THE BALLOON ABOUT 50 MILLIMETERS (MM) IN-VIVO AS IT WAS TAKEN OUT OF THE BODY. NEW BALLOONS ACROSS FRAGMENTED BALLOON WERE PLACED TO SNARE THE FRAGMENT AND A SNARE WAS USED TO ATTEMPT FOR REMOVAL OF THE FRAGMENT. A STENT WAS PLACED TO ADHERE BALLOON AGAINST THE ARTERY WALL. THE PATIENT'S STATUS WAS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 22813602 ↗InjuryAug 7, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE JADE BALLOON WAS USED WITH A NON-ABBOTT SHEATH VIA PEDAL ACCESS TO TREAT A LESION IN LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE BALLOON WAS INFLATED TO 18 ATM FOR 2 MINUTES AND THEN DEFLATED. INDEFLATOR REMAINED HOOKED TO BALLOON AT NEGATIVE PRESSURE WHILE BALLOON WAS WALKED OF WIRE. THERE WAS RESISTANCE AND THE BALLOON SHEARED OFF AT MIDDLE POINT OF BALLOON, LEAVING HALF OF THE BALLOON ABOUT 50MM IN-VIVO AS IT WAS TAKEN OUT OF THE BODY. NEW BALLOONS ACROSS FRAGMENTED BALLOON WAS PLACED TO SNARE THE FRAGMENT AND A SNARE WAS USED TO ATTEMPT FOR REMOVAL OF THE FRAGMENT. A STENT WAS PLACED TO ADHERE BALLOON AGAINST THE ARTERY WALL. ADDITIONAL INFORMATION WAS RECEIVED AND THE PATIENT WAS DISCHARGED.
Patient problems: Foreign Body In Patient
MAUDE report 22742963 ↗InjuryAug 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING PROCEDURE, A JADE BALLOON WAS PLACED IN PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS INFLATED TO 12 ATMOSPHERES. THE BALLOON RUPTURED. DURING REMOVAL, IT WAS NOTICED THAT THE BALLOON HAD BROKEN IN-VIVO AND BECAME COMPLETELY DETACHED. AN ATTEMPT WAS MADE TO ADVANCE ANOTHER WIRE THROUGH THE EXISTING 6F NON-ABBOTT CONTRALATERAL SHEATH, BUT WAS UNSUCCESSFUL. THE PHYSICIAN HAD TO PUNCTURE THE SFA ANTEGRADE DIRECTLY BELOW THE BROKEN BALLOON. A STENT WAS PLACED WITH DIFFICULTY TO ADHERE THE BALLOON AGAINST THE WALL. THERE WAS DELAY IN THE TREATMENT AS IT ADDED 75 TO 90 MINUTES TO THE PROCEDURE WITH TWO ADDITIONAL PUNCTURES THAT WERE REQUIRED. THE PATIENT WAS DISCHARGED AFTER BEDREST.
Patient problems: Foreign Body In Patient
MAUDE report 22724103 ↗InjuryAug 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING PROCEDURE, A JADE BALLOON WAS PLACED IN PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS INFLATED TO 12 ATMOSPHERES. THE BALLOON RUPTURED. DURING REMOVAL, IT WAS NOTICED THAT THE BALLOON HAD BROKEN IN-VIVO AND BECAME COMPLETELY DETACHED. AN ATTEMPT WAS MADE TO ADVANCE ANOTHER WIRE THROUGH THE EXISTING 6F NON-ABBOTT CONTRALATERAL SHEATH, BUT WAS UNSUCCESSFUL. THE PHYSICIAN HAD TO PUNCTURE THE SFA ANTEGRADE DIRECTLY BELOW THE BROKEN BALLOON. A STENT WAS PLACED WITH DIFFICULTY TO ADHERE THE BALLOON AGAINST THE WALL. THERE WAS DELAY IN THE TREATMENT AS IT ADDED 75 TO 90 MINUTES TO THE PROCEDURE WITH TWO ADDITIONAL PUNCTURES THAT WERE REQUIRED. THE PATIENT WAS DISCHARGED AFTER BEDREST.
Patient problems: Foreign Body In Patient
MAUDE report 22724080 ↗InjuryJul 11, 2025Material Separation; Material Separation
IT WAS REPORTED THAT NON-ABBOTT LASER WAS USED FOR ATHERECTOMY TO TREAT A DISEASED SUPERFICIAL FEMORAL ARTERY (SFA). AFTER ATHERECTOMY, A STENT WAS PLACED, POST STENT DILATION WAS PERFORMED WITH A JADE .018 OTW 7.00MMX100MM 150 CM BALLOON. THE BALLOON WAS DILATED UP TO BURST PRESSURE OF 16 ATMOSPHERES (ATM), AND THE BALLOON BURST. THE PHYSICIAN WENT DOUBLE NEGATIVE ON THE BALLOON, PULLED THE BALLOON BACK TO TAKE OUT OF BODY. WHEN BALLOON WAS REMOVED FROM THE BODY, IT WAS EVIDENT ON THE CATHETER THAT ONLY A PIECE OF THE BALLOON WAS STILL ATTACHED. AFTER FLUOROSCOPY, REMANENT OF THE BALLOON APPEARED STILL IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BALLOON WITHIN ANOTHER CATHETER AND WAS UNSUCCESSFUL. THE PATIENT LEFT FOR SURGERY. A CUTDOWN WAS PERFORMED TO REMOVE THE BALLOON FRAGMENTS. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22477545 ↗
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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