Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall EXCOR Pediatric Ventricular Assist Device

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall EXCOR Pediatric Ventricular Assist Device see related information
Date Initiated by Firm May 18, 2018
Date Posted May 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-1618-2023
Recall Event ID 92132
PMA Number P160035 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.
Code Information P10P-001 (UDI-DI: 04260090040102)- Serial Numbers: 1520081 1520100 1520309 1520087 1520345 1720280 1620177 1520367 1520344 1620159 1620696 1620699 1720274 1620693 1620669 1720279 1720276 1720329 1520037 1620161 1620157 1620169 1620620 1620649 1620662 1620652 1620650 1720298 1620664 1620622 1620663 1720299 1520041 1620666 1620178 1421365 1520011 1520079 1520080 1520098 1520099 1520316 1520317 1620162 1620638 1620654 1620668 1620671 1620698 1620667 1620665 1620670 1520038 1520339 1620697 1520349 1520054 1620691 1720277 1720275 1720341 1520055 1520068 1520302 1520343 1520362 1520301 1520318 1520336 1520337 1520355 1421364 1720330 1720351 1620653 1620655 1520036 1520035 1520016 1520017 1520387 1520334 1520371 1620695 1520031 1520033 1520032 1620694 1520026 1520027 1520352 1520347 1620163 1520018 1520333 1520321 1520348 1620621 1720342 1720343 1520354 1421373 1520042 1520050 1520365 1520350 1720331 1520342 1520366 1520381 1520380; P15P-001 (UDI-DI: 04260090040157) - Serial Numbers: ; 1520267 1520268 1520459 1520278 1520277 1620367 1720423 1720549 1520393 1520253 1620364 1620388 1620396 1620456 1720386 1520469 1520486 1520449 1520458 1520392 1520477 1520481 1620210 1620381 1620387 1620429 1620430 1820095 1520247 1520280 1520476 1620199 1620207 1520274 1421261 1520169 1421234 1820074 1820075 1820098 1720430 1820094 1520213 1520181 1520176 1421277 1520177 1520286 1520279 1421273 1520282 1520255 1520281 1820099 1620219 1520291 1520264 1520262 1520265 1620457 1720361 1620438 1720362 1620458 1720389 1620427 1820093 1520395 1520410 1520397 1720435 1720384 1720387 1720551 1520275 1520292 1520297 1520299 1520390 1520401 1520300 1720365 1720378 1720376 1720379 1620368 1620397 1620418 1720437 1720427 1720554 1520400 1520441 1620206 1620220 1620420 1620423 1820067 1720424 1720558 1421263 1421264 1720552 1720553 1520193 1520485 1620440 1620421 1620422 1620366 1520287 1520480 1620385 1520294 P25P-001x01 (UDI-DI: 04260090040119)- Serial Numbers: 1620559 1620486 1620496 1620546 1620562 1620547 1620560 1420509 1420510 1720475 1520597 1720456 1520596 1520598 1720455 1720461 1520593 1620541 1620497 1620585 1720473 1620231 1620498 1520586 1520590 1620597 1420525 1420526 1420496 1420527 1420528 1420494 1420533 1420538 1420536 1620548 1520620 1620543 1720468 1720483 1520599 1720482 1620485 1420567 1620587; P30P-001x01 (UDI-DI: 04260090040126)- Serial Numbers: 1520624 1720212 1620526 1620518 1620500 1520638 1620044 1620042 1720210 1520102 1321159 1520103 1520142 1520143 1620018 1520137 1520623 1520107 1620010 1620046 1620049 1520129 1520654 1520108 1620005 1520132 1520656 1520125 1620501 1520113 1520641 1620527 1520133 1520135; P50P-001 (UDI-DI: 04260090040010)- Serial Numbers: 1720245 1420184 1420196 1720247 1420179 1420134 1420150 1420153 1420142 1420143 1420162 1420164 1420170 1420128 1720248 1420129 1420139 1420132 1420135 1420137 1420138; P60P-001 (UDI-DI: 04260090040027)- Serial Numbers: 1420238 1420258 1420233 1420234 1420236 1520692 1420292 1420290 1420274 1420278
Recalling Firm/
Manufacturer		 BERLIN HEART GMBH
Wiesenweg 10
Berlin Germany
For Additional Information Contact Clinical Affairs Team
281-8639700
Manufacturer Reason
for Recall		 There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.
FDA Determined
Cause 2		 Component design/selection
Action On May 18, 2018, Berlin Heart issued a Safety Communication via E-Mail to affected consignee. The Safety Communication asked consignees to take the following actions: 1. Always follow the information and instructions provided in the Instructions for Use that have been provided to you by Berlin Heart. Information related to the specific issues discussed within the letter is included in Chapter 12 starting on page 115, specifically Section 12.5, and 12.51. 2. Additional information on troubleshooting is found in Chapter 16 starting on page 161. 3. If you have any questions or concerns regarding the communication, please contact Clinical Affairs team directly at 281-863-9700
Quantity in Commerce 335 units
Distribution Distribution to US states of MA, TX, WI, CA, SC, FL, CO, NY, PA, NC, UT, GA, MN, OH, AZ, AL, and Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Berlin Heart Inc.
-
-