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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94464

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 09, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Sophysa S.A.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT

Z-1825-2024
Recall number
Z-1825-2024
Initiated
April 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sophysa S.A.
Quantity
3487 units OUS

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.

Code information

UDI-DI: 03760124131482 OUS Serial Numbers: 22C02558 22C02582 22C07751 22C07753 22C09753 22C09757 22C09772 22C09780 22C09781 22C09783 22C09850 22C11644 22C13089 22C14035 22C14036 22C14151 22C14152 22C14153 22C14154 22C14156 22C14158 22C14159 22C14165 22C14166 22C14167 22C14171 22C14172 22C14173 22C14174 22C14178 23C02554 23C03278 23C03279 23C03280 23C03281 23C03282 23C03283 23C03284 23C03285 23C03286 23C03287 23C03288 23C03289 23C03290 23C03291 23C03295 23C03302 23C03308 23C03310 23C03314 23C03315 23C03316 23C03317 23C07704 23C07710 23C07718 23C60201 23C60202 23C60203 23C60209 23C60210 23C60211 23C60212 23C60227 23C60232 23C60233 23C60240 23C60270 23C60271 23C60273 23C60275 23C60276 23C60277 23C60278 23C60282 23C60283 23C60284 22C22761 22C33393 22C33394 22C33395 22C33396 22C33397 22C33398 22C33642 22C41544 22C41545 22C41546 22C41547 22C41548 22C41553 22C41554 22C41557 22C41558 22C41560 22C41810 22C41811 22C41812 22C41813 22C41814 22C41815 22C41817 22C41818 22C41820 22C41821 22C41822 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Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, NY, TX and the countries of ARGENTINA, CHINA, CZECH REPUBLIC, FRANCE, GREECE, HUNGARY, JAPAN, PAKISTAN, Portugal, ROMANIA, SOUTH AFRICA, SWEDEN, VIETNAM.

device · product 2 of 2

The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT

Z-1826-2024
Recall number
Z-1826-2024
Initiated
April 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sophysa S.A.
Quantity
3175 units- 41 units US; 3134 units OUS

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.

Code information

UDI-DI: 3760124132922 US Serial Numbers: 22D06059 22D06060 22D06745 22D06747 22D06749 22D07240 22D07242 22D07243 22D07246 22D07249 22D07250 22D07251 22D07257 22D08435 22D08436 22D08438 22D08511 22D08512 22D08522 22D08525 22D08526 22D08527 22D08528 22D08529 22D12007 22D12009 22D12012 22D12013 22D12014 22D12016 22D12017 22D12018 22D12019 22D12020 22D12021 22D12022 22D12023 22D12024 22D12025 22D12027 22D12032 OUS S/N: 22D04871 22D04873 22D04875 22D04877 22D04881 22D04907 22D04908 22D04909 22D05006 22D05021 22D09368 22D09376 22D09377 22D09378 22D09379 22D09380 22D09381 22D09382 22D09383 22D09384 22D52761 22D52764 21D20346 21D20353 21D20355 21D20361 21D20367 21D42206 21D42212 21D42215 21D42240 22D00060 22D00064 22D00065 22D00066 22D00067 22D00068 22D00069 22D00070 22D00071 22D00072 22D00074 22D00075 22D00076 22D00077 22D00084 22D00124 22D00240 22D00241 22D00242 22D00244 22D00245 22D00247 22D00248 22D00253 22D00256 22D00258 22D00259 22D00262 22D00263 22D00264 22D00265 22D00267 22D00269 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22D54929 22D54930 22D54932 22D54933 22D54934 22D54935 22D54936 22D54937 22D54938 22D54939 22D54940 22D54941 22D54942 22D54943 22D54945 22D54947 22D55417 22D55418 22D55420 22D55421 22D55422 22D55423 22D55424 22D55425 22D55427 22D55428 22D55429 22D55431 22D55432 22D55433 22D55435 22D55436 22D55437 22D55439 22D55440 22D55441 22D55442 22D55443 22D55444 22D55445 22D55446 22D55447 22D55448 22D55451 22D55452 22D55453 22D55454 22D55455 22D55456 22D55458 22D55459 22D55460 22D55461 22D55462 22D55463 22D55464 22D55465 22D55466 22D55467 22D55468 22D55469 22D55470 22D55471 22D55473 22D55474 22D55482 22D55489 22D55495 22D55503 22D55504 22D55505 22D55506 22D55507 22D55508 22D55509 22D55511 22D55512 22D55513 22D55514 22D55515 22D55516 22D55517 22D55518 22D55519 22D55520 22D55521 22D55522 22D55523 22D55524 22D55525 22D55526 22D55527 22D55528 22D55529 22D55530 22D55776 22D55777 22D55778 22D55779 22D55780 22D55781 22D55782 22D55783 22D55784 22D55785 22D55788 22D55789 22D55790 22D55791 22D55793 22D55794 22D55795 22D55796 22D55797 22D55800 22D55976 22D55978 22D55979 22D55980 22D55981 22D55982 22D55983 22D55984 22D55986 22D55987 22D55988 22D55989 22D55990 22D55991 22D55993 22D55994 22D55995 22D56075 22D56076 22D56077 22D56078 22D56079 22D56080 22D56081 22D56082 22D56083 22D56084 22D56085 22D56086 22D56087 22D56088 22D56089 22D56090 22D56091 22D56092 22D56093 22D56094 22D56095 22D56096 22D56097 22D56098 22D56099 22D56100 22D56101 22D56314 22D56315 22D56322 22D56323 22D56324 22D56325 22D56326 22D56327 22D56328 22D56329 22D56330 22D56331 22D56332 22D56333 22D56334 22D56335 22D56336 22D56337 22D56338 22D56339 22D56340 22D56341 22D56342 22D56343 22D56344 22D56345 22D56346 22D56347 22D56348 22D56588 22D56589 22D60002 22D60003 22D60004 22D60446 22D60447 22D60448 22D60449 23D00003 23D00007 23D00161 23D00162 23D00168 23D00175 23D00176 23D00179 23D00192 23D00194 23D00201 23D00206 23D00288 23D00289 23D00295 23D00296 23D00297 23D00298 23D00299 23D00300 23D00301 23D00302 23D00303 23D00304 23D00305 23D00306 23D00307 23D00309 23D00311 23D00312 23D00316 23D00317 23D00318 23D00319 23D00320 23D00321 23D00322 23D00324 23D00325 23D00326 23D00327 23D00328 23D00329 23D00331 23D00334 23D00336 23D00339 23D00340 23D00342 23D00343 23D00351 23D00360 23D00361 23D00362 23D00363 23D00365 23D00367 23D00538 23D00539 23D00653 23D00654 23D00655 23D00660 23D00667 23D00670 23D00678 23D00688 23D00689 23D00691 23D00693 23D00696 23D00697 23D00698 23D00700 23D00701 23D00702 23D00704 23D00705 23D00706 23D00709 23D00710 23D00711 23D00713 23D00714 23D00715 23D00716 23D00718 23D00719 23D00720 23D00840 23D00850 23D00858 23D00862 23D00871 23D00872 23D00873 23D00875 23D00888 23D00891 23D00893 23D00894 23D00895 23D00898 23D00902 23D00954 23D00976 23D00983 23D00984 23D00985 23D00991 23D00993 23D00994 23D01002 23D01004 23D01005 23D01021 23D01022 23D01050 23D01051 23D01061 23D01062 23D01064 23D01068 23D01069 23D01071 23D01072 23D01073 23D01076 23D01080 23D01084 23D01086 23D01087 23D01246 23D01247 23D01249 23D01328 23D01330 23D01331 23D01332 23D01334 23D01335 23D01336 23D01337 23D01350 23D01353 23D01357 23D01359 23D01360 23D01361 23D01362 23D01364 23D01366 23D01367 23D01368 23D01370 23D01374 23D01376 23D01378 23D01379 23D01380 23D01383 23D01475 23D01667 23D01671 23D01683 23D01684 23D01686 23D01701 23D01703 23D01704 23D01706 23D01708 23D01709 23D01710 23D01711 23D01712 23D01713 23D01714 23D01715 23D01716 23D01717 23D01718 23D01719 23D01720 23D01721 23D01741 23D01758 23D01764 23D01866 23D01881 23D01882 23D01884 23D01885 23D01889 23D01890 23D01891 23D01892 23D01893 23D01895 23D01896 23D01899 23D01900 23D01932 23D01933 23D01938 23D01939 23D01940 23D01941 23D01942 23D01943 23D01944 23D01945 23D01946 23D01947 23D01949 23D02156 23D02201 23D02205 23D02206 23D02208 23D02209 23D02210 23D02212 23D02213 23D02214 23D02215 23D02217 23D02218 23D02220 23D02221 23D02222 23D02223 23D02226 23D02227 23D02229 23D02230 23D02231 23D02232 23D02340 23D02383 23D02386 23D02395 23D05168 23D05169 23D05170 23D05171 23D05172 23D05173 23D05176 23D05177 23D05178 23D05180 23D05276 23D05285 23D05286 23D05287 23D05289 23D05290 23D05292 23D05293 23D05295 23D05296 23D05298 23D05302 23D05303 23D05305 23D05307 23D05313 23D05351 23D05361 23D05362 23D05363 23D05377 23D05379 23D05380 23D05381 23D05383 23D05386 23D05387 23D05393 23D05395 23D05455 23D05461 23D05464 23D05467 23D05468 23D05469 23D05470 23D05471 23D05476 23D05478 23D05483 23D05531 23D05538 23D05546 23D05548 23D05554 23D05555 23D05556 23D05561 23D05562 23D05564 23D05565 23D05566 23D05567 23D05568 23D05569 23D05570 23D05572 23D05573 23D05574 23D05575 23D05578 23D05579 23D05580 23D05581 23D05582 23D05588 23D05637 23D05645 23D05650 23D05654 23D05660 23D05661 23D05871 23D05872 23D05873 23D05874 23D05875 23D05878 23D05879 23D05884 23D05885 23D05886 23D05887 23D05888 23D05889 23D05890 23D05891 23D05892 23D05994 23D06001 23D06004 23D06245 23D06246 23D06247 23D06249 23D06250 23D06251 23D06252 23D06255 23D06256 23D06258 23D06260 23D06261 23D06262 23D06264 23D06266 23D06267 23D06269 23D06271 23D06272 23D06273 23D06274 23D06275 23D06276 23D06277 23D06278 23D06279 23D06284 23D06285 23D06286 23D06312 23D06317 23D06318 23D06323 23D06324 23D06325 23D06332 23D06333 23D06337 23D06342 23D06345 23D06352 23D06360 23D06366 23D06375 23D06377 23D06379 23D06381 23D06382 23D06383 23D06384 23D06385 23D06386 23D06388 23D06390 23D06391 23D06392 23D06393 23D06394 23D06395 23D06396 23D06397 23D06398 23D06399 23D06400 23D06401 23D06402 23D06404 23D06405 23D06407 23D06409 23D06410 23D06411 23D06412 23D06413 23D06414 23D06436 23D06439 23D06443 23D06444 23D06445 23D06446 23D06448 23D06449 23D06450 23D06454 23D06455 23D06457 23D06460 23D06462 23D06469 23D06652 23D06656 23D06659 23D06660 23D06661 23D06662 23D06664 23D06665 23D06666 23D06667 23D06670 23D06711 23D06808 23D06810 23D06812 23D06813 23D06864 23D06865 23D06866 23D06867 23D06868 23D06869 23D06870 23D06871 23D06876 23D06877 23D06962 23D06964 23D06965 23D06966 23D06967 23D06969 23D06970 23D06971 23D06972 23D06973 23D06975 23D06976 23D06977 23D06979 23D06980 23D10091 23D10095 23D10186 23D10187 23D10263 23D10271 23D10282 23D10283 23D10295 23D10296 23D10339 23D10340 23D10341 23D10414 23D10415 23D10416 23D10417 23D10431 23D10434 23D10444 23D10447 23D10456 23D10459 23D10460 23D10461 23D10466 23D12427 23D12432 23D12433 23D12434 23D12435 23D12436 23D12494 23D12495 23D12496 23D12497 23D12536 23D12537 23D12541 23D12554 23D12618 23D12633 23D12634 23D12674 23D12695 23D14645 23D14648 23D14649 23D14650 23D14651 23D14652 23D14655 23D14656 23D14657 23D14659 23D14660 23D14661 23D14662 23D14664 23D14666 23D14668 23D14669 23D14670 23D14671 23D14672 23D14673 23D14674 23D14676 23D14677 23D14678 23D14679 23D14683 23D14685 23D14686 23D14687 23D14826 23D14836 23D14839 23D14844 23D14845 23D14846 23D15026 23D15033 23D15034 23D15203 23D17499 23D17500 23D17501 23D17506 23D17511 23D17513 23D17514 23D17515 23D17517 23D17518 23D17520 23D17522 23D17523 23D17524 23D17526 23D17529 23D17530 22D11655 22D08627 22D01943 22D08513 22D08519 22D08520 22D08603 22D08605 22D08606 22D08607 22D08608 22D08613 22D08614 22D08615 22D08616 22D08620 22D08621 22D08622 22D08624 22D08628 22D08629 22D08633 22D08830 22D00542 22D00546 22D00548 22D00550 22D00551 22D00552 22D00553 22D00559 22D00943 22D01945 22D52851 22D52852 22D53517 22D53518 22D53519 22D53520 22D53522 22D53532 22D53534 22D53538 22D53542 22D54375 22D11663 23D02462 23D02469 22D51594 22D51596 22D52753 22D52765 22D52766 22D30778 22D50616 22D50618 22D50622 22D52850 22D53523 22D53525 22D53527 22D53539 22D08533 22D08648 22D30568 22D30776 22D08439 22D08510 22D08521 22D50625 22D50636 22D50638 22D50690 22D08535 22D08630 22D08632 22D08646

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, NY, TX and the countries of ARGENTINA, CHINA, CZECH REPUBLIC, FRANCE, GREECE, HUNGARY, JAPAN, PAKISTAN, Portugal, ROMANIA, SOUTH AFRICA, SWEDEN, VIETNAM.