RapidCrossRecalls & reported problems across all models
Covidien LP · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 26 models of RapidCross by Covidien LP in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2017 and Sep 11, 2024 — classified as 12 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (18 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 RapidCross problems
Device problems
- Burst Container or Vessel18
- Detachment of Device or Device Component13
- Difficult to Remove5
- Deflation Problem3
- Fracture3
- Leak/Splash3
- Material Fragmentation2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient11
- Insufficient Information4
- Device Embedded In Tissue or Plaque3
- Patient Problem/Medical Problem3
- Foreign Body In Patient2
- Injury2
- Laceration(s)1
RapidCross models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RapidCross™ A14BX025210170Catheter, angioplasty, peripheral, transluminal4 reports
- RapidCross™ A14BX020150170Catheter, angioplasty, peripheral, transluminal3 reports
- RapidCross™ A14BX025210170Catheter, angioplasty, peripheral, transluminal3 reports
- RapidCross™ A14BX040150170Catheter, angioplasty, peripheral, transluminal3 reports
- RapidCross™ A14BX020080170Catheter, angioplasty, peripheral, transluminal2 reports
- RapidCross™ A14BX025080170Catheter, angioplasty, peripheral, transluminal2 reports
- RapidCross™ A14BX020080170Catheter, angioplasty, peripheral, transluminal2 reports
- RapidCross™ A14BX020060170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX025100170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX025150170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX030040170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX030080090Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX030150170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX030210170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX035120170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX040120170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX040150170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX020120170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX025040170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX030080170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX030210170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX035040170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX035060170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX035150170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX040040170Catheter, angioplasty, peripheral, transluminal1 report
- RapidCross™ A14BX040210170Catheter, angioplasty, peripheral, transluminal1 report
Recent RapidCross adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A RAPIDCROSS PTA BALLOON WAS BEING USED FOR TREATMENT. THE IFU WAS FOLLOWED. IT WAS REPORTED THE BALLOON DETACHED AT THE TARGET LESION. THE DETACHED BALLOON WAS REMOVED WITH A SNARE, THE DEVICE WAS SAFELY REMOVED. NO PATIENT INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20191053 ↗InjuryMay 14, 2024Deflation Problem; Deflation Problem
PHYSICIAN ATTEMPTED TO USE A RAPID CROSS PTA BALLOON DILATATION CATHETER WITH A 45CM 6FR NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A FIBROUS LESION IN PATIENTS RIGHT DISTAL ANTERIOR TIBIAL ARTERY (ATA). THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH THE RAPIDCROSS PTA BALLOON. THE VESSEL WAS NOT POST-DILATED. A MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST INFLATION FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. DEFLATION DIFFICULTIES WERE REPORTED. NO ISSUES WERE NOTED DURING INFLATION. BALLOON WAS TAKEN TO NOMINAL INFLATION PRESSURE BUT WOULD NOT DEFLATE. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THE PHYSICIAN CUT THE HUB OFF THE CATHETER TO ALLOW FOR BALLOON DEFLATION. THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19309539 ↗MalfunctionApr 4, 2024Leak/Splash; Device Difficult to Setup or Prepare; Leak/Splash; Device Difficult to Setup or Prepare
A PHYSICIAN WAS USING A RAPID CROSS PTA BALLOON. IT WAS REPORTED THAT THE 0.014 INCH GUIDEWIRE DOES NOT EXIT THROUGH THE CATHETER GUIDEWIRE PORT LATERALLY, BUT EXITS AT THE PORT CONNECTED TO THE INFLATION LUMEN DISTALLY. WHEN ADMINISTERING SALINE THROUGH THE DISTAL INFLATION PORT, THE OPERATOR NOTICED A LEAK OF SALINE THROUGH THE LATERAL CATHETER GUIDEWIRE PORT. THE OPERATOR DECIDED TO USE ANOTHER BALLOON OF THE SAME REFERENCE (B)(4) TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. NO DEFORMATION WAS NOTED ON DEVICE. DEVICE WAS USED TO TREAT TIGHT STENOSIS OF THE DISTAL SUPERFICIAL FEMORAL ARTERY. WHEN THE DEVICE WAS RETURNED FOR EVALUATION IT WAS NOTED THAT THERE WAS A LEAK FROM THE TIP OF THE DEVICE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039718 ↗MalfunctionJun 27, 2023Material Fragmentation
VASCULAR SURGERY PROCEDURE MEDTRONIC RAPID CROSS PTA BALLOON DILATION CATHETER USED DEVICE BROKE APART INSIDE PATIENT ALL PIECES RETRIEVED NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17218728 ↗InjuryJan 30, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
A PHYSICIAN WAS USING A RAPID CROSS PTA BALLOON DURING AN ANGIOPLASTY PROCEDURE. IT WAS REPORTED WITH THE USE OF AN 018 WIRE THEY SELECTED THE ANTERIOR TIBIALIS ARTERY AND ADVANCED A QUICK CROSS CATHETER, SURGEON THEN EXCHANGED THE WIRE FOR AN 014 WIRE. WITH THIS WIRE THEY WERE ABLE TO CROSS THE LESION AND ADVANCED THE QUICK CROSS CATHETER. THEY PERFORMED AN ANGIOGRAM WHICH SHOWED THAT THE CATHETER WAS PLACED IN THE DISTAL DORSALIS PEDIS INTO THE METATARSAL BRANCHES INCLUDING THE THIRD TOE. FOR THIS REASON, THE SURGEON OPTED TO TREAT THIS AREA TO IMPROVE THE CIRCULATION TO THE COMPROMISED TOE. THE PATIENT WAS HEPARINIZED APPROPRIATELY ACCORDING TO WEIGHT WITH A GOAL ACT OF 250. SURGEON OPTED TO USE A QUICK EXCHANGE RAPID CROSS RX 2MM X 80MM RAPID EXCHANGE BALLOON, THIS WAS DONE OVER A WHISPER MS 014 WIRE. SURGEON PERFORMED PROLONGED INFLATION. THEN THE BALLOON WAS TAKEN DOWN, AS SURGICAL TEAM WERE WITHDRAWING THE BALLOON, THE SURGEON NOTED THAT THERE WAS MORE RESISTANCE THAN ANTICIPATED AND THEN SLIGHTLY THERE WAS A SNAP AND SURGEON RETRIEVED THE PROXIMAL END OF THE CATHETER BUT NOT THE BALLOON. THE SURGEON THEN PERFORMED AN ANGIOGRAM AND IT SHOWED THAT THE BALLOON WAS STILL ATTAC
Patient problems: Insufficient Information
MAUDE report 16264451 ↗MalfunctionJan 19, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A RAPIDCROSS BALLOON TO TREAT A LESION AT THE PERONEAL ARTERY. THE IFU WAS FOLLOWED, HOWEVER PHYSICIAN DID NOTE CALCIFIC DIFFUSED DISEASE IN ALL THREE TIBIAL ARTERIES. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE AND 50% CONTRAST, 50% HEPARINIZED SALINE. IT WAS REPORTED THAT THERE WAS A BALLOON BURST AT 6 ATM. THE BALLOON BROKE OFF OF THE CATHETER AND WAS LEFT INSIDE OF THE PATIENT¿S BODY. IT OBSTRUCTED THE PERINEAL ARTERY AND WAS LEFT THERE. THE OTHER TWO TIBIAL ARTERIES WERE PATENT. THE ENTIRE VESSEL WAS LOST DUE TO BEING UNABLE TO RETRIEVE THE BROKEN OFF BALLOON. IT IS UNKNOWN IF THE BALLOON FRAGMENTED BECAUSE THE BALLOON BROKE OFF OF THE CATHETER AND STILL REMAINS IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16203266 ↗InjuryDec 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN WAS USING A RAPID CROSS PTA BALLOONS FOR THE TREATMENT OF A 300MM CALCIFIED LESION IN THE MID/DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY <(>&<)> POPLITEAL ARTERY. THE DEGREE OF TORTUOSITY WAS MILD AND THERE WAS MODERATE CALCIFICATION. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A 6FR NO-MDT SHEATH AND 0.014" NITREX GUIDEWIRE WERE USED. THE BALLOON WAS INFLATED USING A NON-MDT INFLATION DEVICE AND 50 SALINE/50 CONTRAST INFLATION FLUID. THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED BOTH THE BALLOONS DETACHED IN VIVO AND PORTION OF THE DEVICE WHICH REMAINED IN THE PATIENT COULD NOT BE SNARED OR REMOVED AND THE BALLOONS WERE STENTED IN PLACE. A NON MEDTRONIC SNARE WAS USED.
Patient problems: Insufficient Information
MAUDE report 15994526 ↗MalfunctionNov 28, 2022Burst Container or Vessel; Leak/Splash; Material Deformation; Burst Container or Vessel; Leak/Splash; Material Deformation
A PHYSICIAN WAS USING A RAPIDCROSS PTA BALLOON DURING A CROSS-OVER ANGIOPLASTY OF THE RIGHT FEMORAL-POPLITEAL ARTERY. USE OF GUIDES AND PROBES OF SIZE 0.014" AS WELL AS DILATION BALLOONS DUE TO THE PATIENT'S CALCIFIED ARTERY. THE RAPIDCROSS WAS USED TO PERFORM DILATION DURING THE RECANALIZATION. MANEUVER PERFORMED UNDER RADIOLOGICAL CONTROL, AS A RESULT OF USING AN IODINE CONTRAST PRODUCT THE SURGEON NOTICED THAT THE BALLOON WAS PIERCED AND THAT THERE WAS A CRACK. THE DECISION WAS MADE TO REPLACE THIS BALLOON WITH A ANOTHER FROM THE SAME LABORATORY WHICH WAS SUCCESSFULLY USED. NO PATIENT INJURY REPORTED FOR THE PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15868510 ↗MalfunctionNov 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN WAS USING A RAPID CROSS BALLOON FOR THE TREATMENT OF AN UNKNOWN LESION IN THE MID REGION OF THE ANTERIOR TIBIAL ARTERY. THERE WAS MILD TORTUOSITY AND CALCIFICATION. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. THE DEVICE WAS INFLATED USING AN EVEREST INFLATION DEVICE. IT WAS REPORTED AT THE END OF THE PROCEDURE THE BALLOON DETACHED FROM THE CATHETER. DETACHMENT OCCURRED IN VESSEL JUST PROXIMAL TO SHEATH. DETACHED COMPONENT WAS REMOVED. THE PHYSICIAN PULLED THE SHEATH AND USED A CLOSURE DEVICE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15867167 ↗MalfunctionNov 24, 2022Burst Container or Vessel; Burst Container or Vessel
A PHYSICIAN WAS USING A RAPIDCROSS PTA BALLOON FOR THE TREATMENT OF AN UNKNOWN LESION IN THE DISTAL REGION OF THE POSTERIOR TIBIAL ARTERY. THE DEVICE WAS INFLATED USING THE EVEREST INFLATION DEVICE. IT WAS REPORTED THE BALLOON BURST/LEAKED AT 4 ATM. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15860008 ↗MalfunctionOct 17, 2022Leak/Splash; Leak/Splash
A PHYSICIAN WAS ATTEMPTING TO USE A RAPIDCROSS PTA BALLOON. IT WAS REPORTED THE BALLOON WOULD NOT HOLD PRESSURE AND A LEAK WAS DISCOVERED IN THE CATHETER LUMEN. ANOTHER BALLOON WAS USED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15614621 ↗MalfunctionOct 3, 2022Burst Container or Vessel; Burst Container or Vessel
A PHYSICIAN WAS ATTEMPTING TO USE A RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER FOR TREATMENT OF A 60MM CALCIFIED LESION IN THE LEFT TIBIAL/POPLITEAL TRUNK. THE ARTERY DIAMETER WAS 3.5MM WITH MODERATE TORTUOSITY AND CALCIFICATION. THE DEVICE WAS PREPPED WIT NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED WITH SALINE. IT WAS REPORTED A LONGITUDINAL BURST OCCURRED DURING INFLATION. ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETE BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND LASER ATHERECTOMY WAS CARRIED OUT. NO PATIENT INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 15527809 ↗InjurySep 24, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
IT WAS REPORTED THAT A RAPIDCROSS PTA 2.0MM X 150MM X 170CM BALLOON WAS USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 100% STENOSIS IN THE MID POSTERIOR TIBIAL ARTERY. IT WAS REPORTED THAT A 6 FR COOK NON MEDTRONIC SHEATH AND A 014 CHOICE NON MEDTRONIC GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE BALLOON WAS INFLATED WITH A NON MEDTRONIC INFLATION DEVICE. HALF/HALF CONTRAST /SALINE INFLATION FLUID WAS USED. THE DEVICE WAS PREPPED PER IFU. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE BALLOON BURST AT 8 ATMS ON THE FIRST INFLATION. DISTAL PORTION OF BALLOON REMAINED IN VESSEL UPON RETRIEVING AND GOOSE NECK SNARE WAS UTILIZED TO ATTEMPT RETRIEVAL. DETACHMENT OCCURRED UPON REMOVAL ATTEMPT. THE BREAK/FRACTURE OCCURRED AT THE BALLOON. THE DETACHED PORTION OF THE DEVICE REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED BY PLACING A 4.0 COOK ZILVER STENT IN PERONEAL UP TO TPT TO PREVENT PROXIMAL PORTION OF BALLOON FROM EMBOLIZING/MIGRATING. NO FURTHER PATIENT INJURY.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 15475825 ↗MalfunctionApr 14, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
PHYSICIAN WAS ATTEMPTING TO USE A RAPIDCROSS PTA BALLOON DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE MID A NTERIOR TIBIAL ARTERY (ATA). THE VESSEL WAS LITTLE TORTUOUS. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. BALLOON DEFLATION DIFFICULTIES WAS REPORTED WITH DEVICE NOT ABLE TO DEFLATE AT LESION SITE. THE DEFLATION ISSUE WAS NOTED FOLLOWING THE FIRST INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT PHYSICIAN WAS UNABLE TO DEFLATE BALLOON EVEN PULLING NEGATIVE WITH INFLATION DEVICE AND SYRINGE. PHYSICIAN WAS FORCED TO PULL OUT THE BALLOON WHILE IT WAS STILL INFLATED AT 6ATM. NO VESSEL DAMAGE OCCURRED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14111361 ↗MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE THE RAPIDCROSS PTA BALLOON DURING PROCEDURE. IT WAS REPORTED THAT WHILE PERFORMING AN INTERVENTION ON AN ARTERIAL LOWER EXTREMITY CHRONIC TOTAL OCCLUSION,AN ANGIOPLASTY BALLOON WAS INFLATED WITHIN THE LESION. AT SOME POINT THEREAFTER THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE BALLOON AND IT BECAME DETACHED FROM THE SHAFT (CATHETER) WITHIN THE ARTERY. DEVICE REMAINS IN PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 13440618 ↗
Other Covidien LP products
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- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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