DELTAPAQRecalls & reported problems across all models

We found 18 models of DELTAPAQ by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Oct 4, 2016 and Oct 7, 2021 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Stretched” (15 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

Most reported DELTAPAQ problems

DELTAPAQ models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DELTAPAQ DFS101025-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• DELTAPAQ DFS100210-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• DELTAPAQ DFS100310-20

  Device, Vascular, for Promoting Embolization
  2 reports
• DELTAPAQ DFS100515-20

  Device, Vascular, for Promoting Embolization
  2 reports
• DELTAPAQ DFS100720-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• DELTAPAQ DFS100925-20

  Device, Vascular, for Promoting Embolization
  2 reports
• DELTAPAQ DFS100154-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAPAQ DFS100202-20

  Device, Vascular, for Promoting Embolization
  1 report
• DELTAPAQ DFS100204-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAPAQ DFS100206-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAPAQ DFS100258-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAPAQ DFS100250-20

  Device, Vascular, for Promoting Embolization
  1 report
• DELTAPAQ DFS100306-20

  Device, Vascular, for Promoting Embolization
  1 report
• DELTAPAQ DFS100410-20

  Device, Vascular, for Promoting Embolization
  1 report
• DELTAPAQ DFS100510-20

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAPAQ DFS100612-20

  Device, Vascular, for Promoting Embolization
  1 report
• DELTAPAQ DFS100716-20

  Device, Vascular, for Promoting Embolization
  1 report
• DELTAPAQ DFS100820-20

  Device, Vascular, for Promoting Embolization
  1 report

Recent DELTAPAQ adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAPAQ 2MMX10CM SR PLAT COIL (DFS10021020, UNKNOWN LOT) WOULD NOT DETACH WHEN IT ARRIVED AT THE SIGHT FOR DEPLOYMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590165 ↗
• MalfunctionFeb 24, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING THE EMBOLIZATION PORTION OF THE PROCEDURE, A 2MMX6CM SR PLAT DELTAPAQ COIL (DFS10020620, L12665) COULD NOT ADVANCE THROUGH THE DELIVERY SYSTEM FOR DEPLOYMENT. THE RESISTANCE WAS FELT INSIDE THE SL-10 MICROCATHETER (MC). A SYNCHRO-14 WIRE AND OTHER COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE. THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE DELTAPAQ COIL DID NOT APPEAR TO BE DAMAGED AT ANY TIME. THE CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE PATIENT WAS DIAGNOSED WITH OROPHARYNGEAL SQUAMOUS CELL CARCINOMA (SCC) AND PRESENTED WITH LARGE VOLUME ORAL CAVITY HEMORRHAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372468 ↗
• MalfunctionAug 14, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PELVIC VARICOSE VEIN EMBOLIZATION PROCEDURE, THE 7MM X 20CM DELTAPAQ 10 STRETCH RESISTANT COIL (DFS10072020 / S12180) WAS DAMAGED AND DID NOT PROGRESS IN THE CONCOMITANT 150CM X 5CM PROWLER SELECT LPES MICROCATHETER (606S155FX / 30036042). THE DEVICE WAS REMOVED. IT WAS REPORTED THAT THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN SLIGHTLY STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS (B)(6) 2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10411401 ↗
• MalfunctionMar 25, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A SHORT NECK SPLENIC ARTERY ANEURYSM, THE 9MM X 25CM DELTAPAQ 10 STRETCH RESISTANT COIL (DFS10092520 / S10053) WAS CHOSEN AFTER PREVIOUS COILS WERE ADVANCED AND PLACED THROUGH THE PROWLER SELECT PLUS MICROCATHETER. THE DELTAPAQ 10 STRETCH RESISTANCE COIL BECAME IMPEDED IN THE DISTAL THIRD OF THE MICROCATHETER AND COULD NOT BE ADVANCED TO THE TARGET LESION. THE COIL WAS REMOVED TO BE RETURNED FOR EVALUATION AND ANALYSIS. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT ASSOCIATED WITH THE EVENT. THE 9MM X 25CM DELTAPAQ 10 STRETCH RESISTANT COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS KINKED AND STRETCHED. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 3/19/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8450154 ↗
• MalfunctionFeb 26, 2019Material Separation; Stretched; Material Deformation; Material Separation; Stretched; Material Deformation

  A REPORT WAS RECEIVED THAT THE 1.5MM X 4CM DELTAPAQ (DFS10015420/P11766) MICROCOIL PROTRUDED FROM THE GREEN INTRODUCER WHILE ADVANCING THE DEVICE POSITIONING UNIT (DPU) WIRE THROUGH THE INTRODUCER SHEATH. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. EVALUATION OF THE RETURNED DEVICE REVEALED SIGNIFICANT EMBOLIC COIL DAMAGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8372507 ↗
• MalfunctionFeb 20, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, AFTER INSERTING THE 4MM X 10CM DELTAPAQ (DFS10041020/P11548) AND THE 3MM X 6CM ULTIPAQ (CFS10030630/C29956) AND CONNECTING TO THE DETACHMENT CONTROL BOX (DCB), THE RED ¿FAULT¿ LIGHT APPEARED ON THE DCB AND THE COILS COULD NOT BE DETACHED. THE PROCESS WAS REPEATED WITH THE SAME RESULT. REPLACEMENT OF THE CONTROL CABLE AND DCB DID NOT RESOLVE THE ISSUE. THE COILS WERE REMOVED FROM THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT USING ANOTHER SIX COILS. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCTS WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354066 ↗
• MalfunctionNov 26, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE DELTAPAQ 10 STRETCH RESISTANT COIL 7MM X 16CM (DFS10071620 / P10306) WAS DEFECTIVE DURING THE PROCEDURE. THE DELTAPAQ COIL WAS REPLACED AND THE PATIENT WAS TREATED WITH THE REPLACEMENT COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT. THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8104091 ↗
• MalfunctionNov 16, 2018Material Deformation; Material Deformation

  AS REPORTED BY THE (B)(6), DURING USE OF A 9MM X 25CM DELTAPAQ ((B)(4) THERMO-MECHANICAL COIL, COMPRESSION OF THE ¿SPRING¿ WAS NOTED, MAKING IT IMPOSSIBLE TO ¿PROGRESS¿. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080680 ↗
• MalfunctionNov 5, 2018Separation Failure; Material Twisted/Bent; Separation Failure; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TO ISOLATE THE VEIN WHICH FORMED A BUBBLE ON A (B)(6)-YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY OF ARTERIOVENOUS FISTULA, THE DELTAPAQ 10 STRETCH RESISTANT 5MM X 15CM COIL (DFS10051520 / S10355) FAILED TO DETACH AT THE SITE OF THE TARGET LESION. THE COIL WAS REMOVED AND DURING REMOVAL, THE COIL BECAME BENT AND THE DELIVERY WIRE BECAME DAMAGED. IT WAS CONFIRMED THAT NO DAMAGE WAS NOTED ON THE DEVICE PRIOR TO ITS USE DURING THE PROCEDURE. THE REPORTED ISSUE DID NOT CAUSE ANY PATIENT ADVERSE EVENT AND RESULTED IN NO PROCEDURAL DELAY. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS; THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040000 ↗
• MalfunctionNov 5, 2018Separation Failure; Material Twisted/Bent; Separation Failure; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TO ISOLATE THE VEIN WHICH FORMED A BUBBLE ON A (B)(6) YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY OF ARTERIOVENOUS FISTULA, THE DELTAPAQ 10 STRETCH RESISTANT 5MM X 15CM COIL (DFS10051520/S10355) FAILED TO DETACH AT THE SITE OF THE TARGET LESION. THE COIL WAS REMOVED AND DURING REMOVAL, THE COIL BECAME BENT AND THE DELIVERY WIRE BECAME DAMAGED. IT WAS CONFIRMED THAT NO DAMAGE WAS NOTED ON THE DEVICE PRIOR TO ITS USE DURING THE PROCEDURE. THE REPORTED ISSUE DID NOT CAUSE ANY PATIENT ADVERSE EVENT AND RESULTED IN NO PROCEDURAL DELAY. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS; THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039988 ↗
• MalfunctionOct 10, 2018Stretched; Separation Failure; Material Twisted/Bent; Stretched; Separation Failure; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE, THE 7MM X 20CM DELTAPAQ SR PLAT (DFS10072020/S11333) THERMO-MECHANICAL COIL FAILED TO DETACH. THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952053 ↗
• MalfunctionJul 23, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE DELTAPAQ 10 STRETCH RESISTANT COIL 2.5MM X 8CM (DFS10025820 / P11442) WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712579 ↗
• MalfunctionDec 28, 2017Positioning Failure; Stretched; Positioning Failure; Stretched

  AS REPORTED BY A PHYSICIAN, DURING COIL EMBOLIZATION OF THE RIGHT INTERNAL CAROTID ARTERY, AN ENPOWER DETACHMENT CONTROL BOX (DCB00000500/F42808) WAS UNABLE TO DETACH A DELTAPAQ COIL (DFS10021020/ S14661). UPON ATTEMPTING TO DETACH THE COIL, A RED LIGHT WAS VISIBLE ON THE BOX. THEY TURNED THE BOX OFF AND ON AND THE DCB SEEMED TO REINITIALIZE, BUT THE ACCOUNT USED ANOTHER DCB FOR THE REST OF THE COILING PROCEDURE; HOWEVER, THE DELTAPAQ CONTINUED TO NOT BE ABLE TO DETACH WITH THE NEW BOX. THE COIL WAS REMOVED AND SET ASIDE TO BE RETURNED FOR EVALUATION. THE PHYSICIAN CONTINUED TO SUCCESSFULLY COIL THE RIGHT ICA ANEURYSM WITH NO FURTHER ISSUES USING THE REPLACEMENT DCB. BOTH COMPLAINT PRODUCTS HAD BEEN PREPPED AND USED AS PER THE IFU AND ALL CONNECTIONS FIT PROPERLY WITHOUT NEED FOR EXCESSIVE FORCE. NEITHER DEVICE APPEARED DAMAGED. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. IT WAS REPORTED THAT THE PRODUCTS WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7153697 ↗
• MalfunctionJun 8, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN INTRACRANIAL ANEURYSM COILING PROCEDURE THE PHYSICIAN HAD DIFFICULTY DETACHING A DELTAPAQ 5MM X 10 CM (DFS10051020/C27177) COIL USING AN ENPOWER DETACHMENT CONTROL BOX (DCB00000500/F75871) AND CODMAN CONNECTING CABLE (CCB00015700/S12885). REPORTEDLY THE DELTAPAQ COIL FAILED TO DETACH FOUR TIMES WHEN BEING USED WITH THE ENPOWER DETACHMENT CONTROL BOX. THE SIGNAL DIODE AND THE SOUND INDICATED THAT THE COIL DETACHED HOWEVER USING FLUOROSCOPY THE PHYSICIAN CONCLUDED THAT THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. AFTER THE FOUR ATTEMPTS TO DETACH THE COIL, THE ENPOWER DCB BOX AND THE CODMAN CABLE WERE EXCHANGED FOR ANOTHER BOX AND CABLE. THE COIL DETACHED AFTER THREE-FOUR ATTEMPTS WITH THE NEW ENPOWER DCB BOX AND CABLE. IT WAS REPORTED THAT THE POSITION OF THE IMPLANTED COIL WAS SATISFACTORY; NO HARM WAS DONE TO THE PATIENT, MRS 0. THE PROCEDURE WAS FOR TREATMENT OF UNRUPTURED LEFT MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM, VESSELS WERE DIFFUSE ATHEROSCLEROTIC. REPORTEDLY THE (B)(6)-YEAR-OLD FEMALE PATIENT WAS PREVIOUSLY TREATED IN 2016 FOR A RUPTURED RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM. THERE WERE NO DAMAGES NOTED TO THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6621880 ↗
• MalfunctionMay 24, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COILING OF A BASILAR ANEURYSM, A DELTAPAQ COIL (DFS10020220/C13011) FAILED TO DETACH USING A DETACHMENT CONTROL BOX (DCB00000500/LOT UNK) AND A CABLE (ECB00018200, LOT UNK). THE COIL WAS THE SECOND COIL USED. AFTER SUCCESSFUL POSITIONING IN THE ANEURYSM THE COIL COULD NOT BE DETACHED AFTER SEVERAL ATTEMPTS. THE COIL WAS RECOVERED WITHOUT DETACHMENT. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED AND NO FAULT LIGHT WAS SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITOUT APPLICATION OF EXCESSIVE FORCE. THE NEXT COIL COULD BE PLACED SUCCESSFULLY WITH THE SL 10 MICROCATHETER USING THE SAME DETACHMENT CONTROL BOX AND CABLE. THE CABLE AND DETACHMENT BOX WERE DISCARDED AFTER THE PROCEDURE. THERE WAS NO PATIENT HARM OR SURGICAL DELAY GREATER THAN 30 MINUTES REPORTED. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6588028 ↗

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